第一篇:FDA可在年度報(bào)告中提出的變更指南 中英文對照范文
201006 FDA行業(yè)指南 可在年報(bào)中報(bào)告的CMC已批準(zhǔn)生產(chǎn)變更草案(中英文)2013-01-22 16:04:09| 分類: FDA|字號 訂閱
Guidance for Industry
行業(yè)指南
CMC Postapproval Manufacturing Changes Reportable in Annual Reports
可在年報(bào)中報(bào)告的CMC已批準(zhǔn)生產(chǎn)變更
DRAFT GUIDANCE
指南草案
This guidance document is being distributed for comment purposes
only.本指南文件僅供征求意見。
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.Submit comments to the Division of Dockets Management(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852.All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.For questions regarding this draft document contact(CDER)Jon E.Clark at 301-796-2400.關(guān)于本草案的問題請聯(lián)系CDER Jon E.Clark at 301-796-2400
U.S.Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research(CDER)
June 2010
CMC
Guidance for Industry
行業(yè)指南
CMC Postapproval Manufacturing Changes Reportable in Annual Reports
可在年報(bào)中報(bào)告的CMC已批準(zhǔn)生產(chǎn)變更 Additional copies are available from:
Office of Communications
Division of Drug Information, WO51, Room 2201 Center for Drug
Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave.Silver Spring, MD 20993-0002 Phone: 301-796-3400;Fax: 301-847-8714
druginfo@fda.hhs.gov
www.tmdps.cnplianceRegulatoryInformation/Guidan
ces/default.htm
U.S.Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research(CDER)
June 2010
TABLE OF CONTENTS I.INTRODUCTION.介紹............................................................................................................1 II.BACKGROUND.背景..............................................................................................................1 III.DISCUSSION..討論..................................................................................................................2 IV.CONTENTS OF ANNUAL REPORT NOTIFICATION.年報(bào)通知的內(nèi)容.........................4 APPENDIX A: CMC POSTAPROVAL MANUFACTURING CHANGES REPORTABLE IN ANNUAL REPORTS......................................................附件A:可在年報(bào)中報(bào)告的CMC已批準(zhǔn)生產(chǎn)變更
Guidance for Industry[1] 行業(yè)指南
CMC Postapproval Manufacturing Changes Reportable in Annual Reports
可在年報(bào)中報(bào)告的CMC已批準(zhǔn)生產(chǎn)變更
This draft guidance, when finalized, will represent the Food and Drug Administration’s(FDA’s)current thinking on this topic.It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.本指南草案,如果最終定稿,代表的是FDA目前對這一專題的態(tài)度。它并未建立或賦予任何個(gè)人任何權(quán)利,并不與FDA或公眾有任何綁定。你可以使用任何一種替代方法,只要所用的方法滿足成文的法規(guī)要求。如果你想要討論一個(gè)替代方法,請與FDA負(fù)責(zé)實(shí)施本指南的相關(guān)人員聯(lián)系。如果你無法無法識別要聯(lián)系的人,可以撥打本指南首頁所列的相應(yīng)的電話號。
I.INTRODUCTION 介紹 This guidance provides recommendations to holders of new drug applications(NDAs)and abbreviated new drug applications(ANDAs)regarding the types of changes that may be reported in annual reports.Specifically, the guidance describes chemistry, manufacturing, and controls(CMC)postapproval manufacturing changes that we have determined will likely present minimal potential to have adverse effects on product quality and, therefore, may be reported by applicants in an annual report.[2][3] 本指南給NDA和ANDA持有人提供建議,說明哪些變更可以在年報(bào)中進(jìn)行報(bào)告。指南專門針對的是化學(xué)、生產(chǎn)和控制(CMC)批準(zhǔn)后生產(chǎn)變更,哪些可能對產(chǎn)品質(zhì)量產(chǎn)生潛在不良影響很小,因此可以在年度報(bào)告中進(jìn)行報(bào)告。
Appendix A lists the CMC postapproval manufacturing changes previously submitted under manufacturing supplements that we have determined to be generally of low risk to product quality(product identity, strength, quality, purity, and potency as they relate to the safety or effectiveness of the product).附件A列出了CMC已批準(zhǔn)生產(chǎn)變更,我們認(rèn)為一般來說對產(chǎn)品質(zhì)量(與產(chǎn)品安全性或有效性相關(guān)的屬性,如產(chǎn)品鑒別、劑量、質(zhì)量、純度和效價(jià))影響較低,但之前要求在生產(chǎn)增補(bǔ)中提交的變更。
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.The use of the word should in Agency guidances means that something is suggested or recommended, but not required.FDA的指南文件,包括本文件,并未設(shè)立法律強(qiáng)制責(zé)任。它只是描述了當(dāng)局目前對某一主題的想法,如果未引用特定的法律法規(guī)要求的話,應(yīng)僅作為推薦。“應(yīng)當(dāng)should”一詞在指南中表示建議或推薦的做法,并非強(qiáng)制。
II.BACKGROUND 背景
An applicant must notify FDA of a change to an approved application in accordance with all statutory and regulatory requirements—including section 506A of the Federal Food, Drug, and Cosmetic Act(21 U.S.C.356a)(the Act), which was added by section 116 of the Food and Drug Modernization Act,[4] and 21 CFR 314.70.Section 506A of the Act provides requirements for making and reporting manufacturing changes to an approved application and for distributing a drug product made with such changes.Under 21 CFR 314.70, all postapproval CMC changes beyond the established variations in an approved NDA and ANDA are categorized into one of three reporting categories: major, moderate, or minor.對于已根據(jù)相關(guān)的法規(guī)要求—包括聯(lián)邦食品藥品和化妝品法案(21 U.S.C.356a)第506A條(該條款經(jīng)由食品和藥品現(xiàn)代化法案和21CFR第314.70條增加)獲得批準(zhǔn)的申請,申請人必須將相關(guān)變更通知FDA。法案的第506A條說明了對已批準(zhǔn)的申請生產(chǎn)變更報(bào)告要求,和對藥品的銷售變更報(bào)告要求。根據(jù)21CFR314.70,所有超出已批準(zhǔn)的NDA和ANDA中已有變更范圍的預(yù)批準(zhǔn)CMC變更均屬于三個(gè)報(bào)告類別之一:重大、中等、輕微。
If a change is considered to be major, an applicant must submit and receive FDA approval of a supplement before the product made with the manufacturing change is distributed.If a change is considered to be moderate, an applicant must submit a supplement at least 30 days before the product is distributed or, in some cases, submit a supplement at the time of distribution.If a change is considered to be minor, an applicant may proceed with the change, but must notify FDA of the change in an annual report.For any change, applicants must assess the effects of the change as they relate to product safety and efficacy and demonstrate those effects through appropriate studies to determine whether it would be more appropriate to submit a supplement.For additional background information regarding the reporting categories for NDAs and ANDAs, see FDA’s guidance for industry on Changes to an Approved NDA or ANDA(April 2004).[5] 如果變更被作為是重大變更,則申請人必須提交變更至FDA,并在收到FDA批準(zhǔn)后才能將變更后工藝生產(chǎn)的產(chǎn)品用于銷售。如果變更被作為是中等,申請人必須在產(chǎn)品銷售前30天提交變更申請,或在某些情況下,在銷售同時(shí)提交變更申請。如果變更被作為是輕微的,則申請人可以直接進(jìn)行變更,但必須在變更當(dāng)年的年報(bào)中通知FDA。對于任何變更,申請人均必須評價(jià)變更對產(chǎn)品安全性和有效性的影響,通過適當(dāng)?shù)难芯孔C明該變更是否需要提交變更申請。更多與NDA和ANDA報(bào)告分類相關(guān)的背景資料,請參見FDA指南“已批準(zhǔn)的NDA和ANDA的變更”(2004年4月)(注釋5)。
In our September 2004 final report, Pharmaceutical Current Good Manufacturing Practices(CGMPs)for the 21st Century – A Risk-Based Approach(Pharmaceutical Product Quality Initiative), FDA stated that to keep pace with the many advances in quality management practices in manufacturing and to enable the Agency to more effectively allocate our limited regulatory resources, we would implement a cooperative, risk-based approach for regulating pharmaceutical manufacturing.As part of this approach, FDA determined that to provide the most effective public health protection, our CMC regulatory review should be based on an understanding of product risk and how best to manage this risk.在我們2004年9月最終報(bào)告“21世紀(jì)藥品CGMP—基于風(fēng)險(xiǎn)的方法”(藥品質(zhì)量創(chuàng)新)中,F(xiàn)DA申明繼續(xù)進(jìn)行質(zhì)量管理規(guī)范倡議,促進(jìn)當(dāng)局更有效利用我們有限的法規(guī)資源。我們將建立一個(gè)合作的,基于風(fēng)險(xiǎn)的方法對藥品生產(chǎn)進(jìn)行管理。作為該方法的一部分,F(xiàn)DA決定提供更有效的公共安全保護(hù),我們的CMC法規(guī)審核將基于對產(chǎn)品風(fēng)險(xiǎn)的理解,以及如何更好地管理這種風(fēng)險(xiǎn)。
In addition to the requirements in section 506A of the Act and 21 CFR 314.70, applicants are required to comply with other applicable laws and regulations, including the CGMP for Finished Pharmaceutical regulations in 21 CFR Parts 210 and 211.除了法案第506A部分和21CFR 314.70之外,申請人還需要符合其它與申報(bào)相關(guān)的法律法規(guī),包括在21CFR(美國聯(lián)邦法規(guī))第210和211中關(guān)于制劑CGMP的法規(guī)。
III.DISCUSSION 討論
The number of CMC manufacturing supplements for NDAs and ANDAs has continued to increase over the last several years.In connection with FDA’s Pharmaceutical Product Quality Initiative and our risk-based approach to CMC review, we have evaluated the types of changes that have been submitted in CMC postapproval manufacturing supplements and determined that many of the changes being reported present very low risk to the quality of the product and do not need to be submitted in supplements.在過去幾年中,對NDA和ANDA的CMC生產(chǎn)變更申請數(shù)目持續(xù)增長。與FDA的“藥品質(zhì)量倡議”和我們對CMC基于風(fēng)險(xiǎn)的審核方法相關(guān)連,我們對已提交的CMC批準(zhǔn)后生產(chǎn)變更進(jìn)行了評價(jià),并認(rèn)為其中許多變更對產(chǎn)品質(zhì)量的風(fēng)險(xiǎn)極小,不需要提交變更批準(zhǔn)。
Based on this recent evaluation, we developed a list(see Appendix A)to provide current recommendations to companies regarding which postapproval manufacturing changes for NDAs and ANDAs may be considered to have a minimal potential for an adverse effect on the identity, strength, quality, purity, or potency of the drug product and, therefore, may be classified as a change reportable in an annual report(e.g., notification of a change after implementation)rather than in a supplement.The changes are categorized according to types of manufacturing changes and are either additions or revisions to the classification of changes listed in the guidance, Changes to an Approved NDA or ANDA.基于最近的評價(jià),我們列出了一個(gè)清單(見附件A),向公司建議,對于一些可以認(rèn)為對藥品的鑒別、劑量、質(zhì)量、純度或效價(jià)只有非常小的潛在負(fù)面影響的已批準(zhǔn)的NDA和ANDA生產(chǎn)變更,可以歸類為年報(bào)變更(例如實(shí)施后通知類型),而不需要提交增補(bǔ)。根據(jù)生產(chǎn)變更的類型分類的變更,以及對變更分類的增加和修訂已在指南“已批準(zhǔn)NDA或ANDA”中列出。
Thus, if you are submitting supplemental applications that are based on the recommendations for CMC changes provided in Changes to an Approved NDA or ANDA, you also should refer to the list of risk-based recommendations that are provided in Appendix A of this guidance to determine if a particular change may now be reported in an annual report.[6] In addition, the recommendations in this guidance should help clarify when to submit a supplement and when a change may be reported in an annual report.因此,如果你正準(zhǔn)備根據(jù)“已批準(zhǔn)NDA或ANDA”中CMC變更建議提交增補(bǔ)申請,你需要同時(shí)參考基于風(fēng)險(xiǎn)的建議清單,該清單是本指南附件A,以決定某個(gè)具體的變更現(xiàn)在是否可以在年報(bào)中報(bào)告。另外,本指南中的建議可以幫助澄清什么時(shí)候需要提交一個(gè)增補(bǔ),什么時(shí)候變更可以包括在年報(bào)中。
We expect NDA and ANDA holders to evaluate the specific change that they are planning to make in the context of their particular circumstances to determine whether the proposed change would present a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.Based on such an analysis, an NDA or ANDA holder may decide that a change described in Appendix A would more appropriately be submitted as a supplement rather than in an annual report.We, therefore, consider this guidance to provide recommendations for changes that may be appropriately submitted in an annual report rather than to provide a mandatory requirement for reporting these changes in annual reports pursuant to 21 CFR 314.70(a)(3).[7] 我們希望NDA和ANDA持有人對具體的計(jì)劃中的變更進(jìn)行評價(jià),根據(jù)其具體的環(huán)境來決定提議的變更是否對藥品的鑒別、劑量、質(zhì)量、純度或效價(jià)只有非常小的潛在負(fù)面影響?;谠摲治?,NDA或ANDA持有人可以決定在附件A中所述的變更是否更適合提交一個(gè)增補(bǔ),而不是在年報(bào)中報(bào)告。在此,我們認(rèn)為本指南僅是提供一些建議,說明一些變更可能可以在年報(bào)中報(bào)告,而不是根據(jù)21CFR 314.70(a)(3)強(qiáng)制要求這些變更必須在年報(bào)中報(bào)告。
Applicants should remember that regardless of the reporting category for the postapproval manufacturing change, they are required to comply with the CGMP for Finished Pharmaceuticals regulations at 21 CFR Parts 210 and 211.Also, applicants should note FDA’s recommendations for active pharmaceutical ingredient manufacturing that are provided in the guidance for industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.CGMP regulations for finished pharmaceuticals contain specific requirements relevant to the types of changes addressed in this guidance, and compliance with the CGMP regulations is required regardless of how the change is reported to the Agency.CGMP requirements include the need to qualify equipment as suitable for its intended use, the need to assure validated test methods and ongoing state of control of manufacturing processes, and the requirement to maintain appropriate written procedures that the quality unit has reviewed and approved.[8] 申請人應(yīng)記住,不管已批準(zhǔn)的生產(chǎn)變更如何分類,這些變更都需要符合21CFR 210和211中CGMP對制劑法規(guī)的要求。同時(shí),申請人還要注意FDA對活性原料藥生產(chǎn)的建議已包括在行業(yè)指南“Q7A 原料藥GMP”中。CGMP對制劑的法規(guī)包括對本指南中所述的變更類型的特定要求,不管變更類型如何,所有變更均需要符合CGMP法規(guī)要求。CGMP要求包括了需要確認(rèn)設(shè)備是否符合其用途,需要使用驗(yàn)證過的檢驗(yàn)方法,生產(chǎn)工藝應(yīng)處于受控狀態(tài),需要維護(hù)適當(dāng)、經(jīng)過質(zhì)量部分審核和批準(zhǔn)的書面程序。
If you have specific questions associated with whether or not the change may be classified as requiring a supplement or is reportable in an annual report, we recommend that you contact the appropriate CDER review division in the Office of New Drug Quality Assessment(ONDQA), Office of Generic Drugs(OGD), or New Drug Microbiology Staff(OPS-NDMS).如有關(guān)于某個(gè)變更是否需要提交增補(bǔ)還是可以在年報(bào)中報(bào)告的問題,建議聯(lián)系我們ONDQA的CDER審核部門、OGD或OPS-NDMS.IV.CONTENTS OF ANNUAL REPORT NOTIFICATION 年度通知的內(nèi)容 To submit a notification of change in an annual report in accordance with 21 CFR 314.81(b)(2)(iv)(b)and 314.70(d)(3), the applicant must include a full description of the CMC changes that were made that the applicant believes did not require a supplemental application under sections 314.70(b)and(c).This description should include a(1)list of each change by the date the change was made;(2)relevant summary of data from studies and tests performed to evaluate the effects of the change, including cross references to validation protocols and standard operating procedures and policies;and(3)list of all drug products involved.The applicant should describe each change in an annual report in enough detail to allow us to quickly determine whether the appropriate reporting category has been used.In addition, the applicant should include the list of changes in the summary section of the annual report.[9] If the submitted change is inappropriate for an annual report, the applicant will be notified of the correct category and additional information may be requested.為使用年報(bào)中通知的變更符合21CFR 314.81(b)(2)(iv)(b)和314.70(d)(3)的要求,申請人必須在年報(bào)中包括關(guān)于CMC變更的完整描述,說明申請人認(rèn)為該變更不需要根據(jù)、314.70(b)和(c)部分提交增補(bǔ)。該描述應(yīng)包括(1)變更清單(以實(shí)施日期為序)(2)用以評價(jià)變更影響的研究和檢測數(shù)據(jù)總結(jié),包括驗(yàn)證方案、標(biāo)準(zhǔn)操作程序和方針的交叉引用,(3)所有受影響產(chǎn)品的清單。申請人應(yīng)在年報(bào)中對每個(gè)變更進(jìn)行詳細(xì)描述,使得審核人員可以快速?zèng)Q定該變更采用年報(bào)報(bào)告是否合適。另外,申請人應(yīng)在年報(bào)的概述部分包括一個(gè)變更清單(注釋9)。如果提交的變更不應(yīng)該在年報(bào)中進(jìn)行報(bào)告,申請人將被告知正確的分類是什么,并會(huì)被要求補(bǔ)充資料。
APPENDIX A: CMC POSTAPROVAL MANUFACTURING CHANGES REPORTABLE IN ANNUAL REPORTS
附件A:可在年報(bào)中報(bào)告的CMC生產(chǎn)類變更 Components and Composition 組件和成份 1.1 Elimination or reduction of an overage from the drug product manufacturing batch formula that was previously used to compensate for manufacturing losses.Note that this does not apply to loss of potency during storage.去除或減少之前用于補(bǔ)償生產(chǎn)損耗而比處方多出來的部分。注意本點(diǎn)不適用于在存貯過程中會(huì)損失的效價(jià)。
1.2 Change in qualitative and quantitative coating formulation for immediate-release solid dosage forms if the coating material and quantity have been approved in another product[10] and the change in the formulation does not alter release of the drug.立即放行固體制劑包衣配方及數(shù)量變更,而該變更后的包衣材料和數(shù)據(jù)已在另一產(chǎn)品中得到批準(zhǔn),且西方變更不會(huì)改變藥品的放行。
1.3 New supplier of inactive ingredients that have a minimal effect on product performance in the drug product, providing that acceptance criteria remain unchanged.活性成分增加新供應(yīng)商,該活性成分對制劑產(chǎn)品性能影響極小,且保持可接受標(biāo)準(zhǔn)不變。Manufacturing Sites 生產(chǎn)場所
2.1 Modification of an approved manufacturing facility that does not affect a product manufacturing area or sterility assurance and does not change product quality or specifications.對已批準(zhǔn)的生產(chǎn)場所進(jìn)行修改,不影響產(chǎn)品生產(chǎn)區(qū)域或無菌區(qū)域,不影響產(chǎn)品質(zhì)量或標(biāo)準(zhǔn)。
2.2 Addition of barriers to prevent routine in-process human intervention in a filling or compounding area that is qualified and validated by established procedures.增加隔斷,以保護(hù)充填或合成區(qū)域不受常規(guī)人流干擾,并經(jīng)過已有程序確認(rèn)和驗(yàn)證
2.3 Manufacture of an additional drug product(including investigational or developmental products)in an approved multiple-product area that is producing another product(s)if: 在已批準(zhǔn)的多功能區(qū)域生產(chǎn)另一種藥品(包括臨床或研發(fā)產(chǎn)品),如果滿足以下條件 2.3.1 specific identity tests exist to differentiate between all products manufactured at the facility;and 有專屬性鑒別試驗(yàn)可以區(qū)別在該場所生產(chǎn)的任何產(chǎn)品,且
2.3.2 a change-over procedure between manufacturing processes is established;and 建立了更換產(chǎn)品程序,且
2.3.3 the products do not represent an additional level of risk.Additional levels of risk might include, but are not limited to, the manufacture of highly toxic or potent products, highly immunogenic or allergenic products(e.g., penicillin), products that can accelerate degradation of another product(e.g., enzymes), products that represent a new or added risk for adventitious agents, or a product for adults added to a line manufacturing pediatric products.所有產(chǎn)品風(fēng)險(xiǎn)水平不會(huì)增加。風(fēng)險(xiǎn)水平增加可能包括,但不僅限于,高毒性或高效價(jià)產(chǎn)品,高免疫性或致敏性產(chǎn)品(例如,青霉素),會(huì)加快另一產(chǎn)品降解的產(chǎn)品(例如,酶),引入新的或外來風(fēng)險(xiǎn)的產(chǎn)品,或成人用藥增加到幼兒用藥生產(chǎn)線上。Manufacturing Process 生產(chǎn)工藝
3.1 Process changes including any of the following: 包括以下任一內(nèi)容的工藝變更
3.1.1 Addition of a sieving step(s)for aggregate removal if it occurs under nonaseptic conditions.在非無菌條件下增加過篩步驟,以除去團(tuán)料
3.1.2 Changes in mixing times for immediate-release solid oral dosage forms and for solution products.立即放行的固體口服制劑和液體產(chǎn)品混合時(shí)間變更
3.1.3 Changes in drying times for immediate-release solid oral dosage forms.立即放行的口服固體制劑干燥時(shí)間變更
3.2 A scale change of pooled or separated batches to perform the next step in the manufacturing process if all batches meet the approved in-process control limits and the critical operating parameters for the next step remain unaffected.在所有批準(zhǔn)均符合已批準(zhǔn)的過程控制限度,下一步關(guān)鍵操作參數(shù)均保持不受影響的前提下,對還需要進(jìn)行下一步生產(chǎn)工藝的收集液體量或子批次批量進(jìn)行變更。
3.3 Replacement of equipment with that of the same design and operating principle that does not affect the process methodology or in-process control limits, with the exception of equipment used in aseptic processing(e.g., new filling line, new lyophilizer).更換設(shè)備,設(shè)備設(shè)計(jì)和操作原理相同,不影響工藝操作方法或過程控制限度,無菌工藝設(shè)備除外(例如新的充填線、新的凍干器)
3.4 Addition of a duplicate process chain or unit process in the drug substance and drug product manufacturing process with no change in in-process control limits or product specifications.原料藥和制劑生產(chǎn)中增加一套同樣的工藝設(shè)備或單元,對過程控制限度或產(chǎn)品質(zhì)量標(biāo)準(zhǔn)不進(jìn)行變更。
3.5 Addition of, deletion of, or change in a reprocessing protocol for refiltrations to control bioburden because of integrity test failures.由于整體檢測失敗,增加、刪除或變更控制微生物的過濾工藝
3.6 Reduction of open handling steps if there is an improvement with no change to the process(e.g., implementation of aseptic connection devices to replace flame protection procedures).不改變工藝無改進(jìn)意義情況下減少敞開操作步驟(例如,采用無菌連接設(shè)備替換防火保護(hù)操作程序)
3.7 Changes to filtration process parameters(such as flow rate, pressure, time, or volume, but not filter materials or pore size)that are within currently validated parameters and therefore would not warrant new validation studies for the new parameters.在驗(yàn)證過的參數(shù)范圍內(nèi),對過濾工藝參數(shù)進(jìn)行變更(例如流速、壓力、時(shí)間或容量,但不變更過濾材質(zhì)或孔徑),但不對新的參數(shù)進(jìn)行新的驗(yàn)證。
3.8 For sterile drug products, change from a qualified sterilization chamber(ethylene oxide(EtO), autoclave)to another of the same design and operating principle for container/closure preparation when the new chamber and load configurations are validated to operate within the previously validated parameters.This does not include situations that change the validation parameters.無菌原料藥的包裝/容器制備滅菌用具,從驗(yàn)證過的滅菌器(環(huán)氧乙烷EtO自動(dòng)滅菌器)改為相同設(shè)計(jì)相同操作原理的設(shè)備,且新的滅菌器參數(shù)經(jīng)過驗(yàn)證,在原驗(yàn)證過的參數(shù)下可以操作的。這里不包括驗(yàn)證參數(shù)變更的情況。Specifications 質(zhì)量標(biāo)準(zhǔn)
4.1 Addition of a specification for existing excipients.增加已有輔料的質(zhì)量標(biāo)準(zhǔn)
4.2 Change to a drug substance or drug product to comply with the official compendia can be reported in an annual report if it is: 變更原料藥或藥品的質(zhì)量標(biāo)準(zhǔn),使符合官方藥典,符合下列情形時(shí)可在年報(bào)中報(bào)告
4.2.1 A change to tighten an existing acceptance criterion;or 該變更加嚴(yán)已有的可接受標(biāo)準(zhǔn),或
4.2.2 Other changes, except for changes to assays, impurities, product-related substances, or biological activities in approved NDAs and ANDAs.其它變更,變更不涉及已批準(zhǔn)的NDA或ANDA的含量、雜質(zhì)、產(chǎn)品有關(guān)物質(zhì)或生物活性
4.3 Change in the approved analytical procedure if the revised method maintains basic test methodology and provides equivalent or increased assurance that the drug substance or drug product will have the characteristics of identity, strength, quality, purity, or potency that it claims to have or is represented to possess and the acceptance criteria remain unchanged(e.g., change in the flow rate or sample preparation for a high performance liquid chromatography(HPLC)method).已批準(zhǔn)的檢驗(yàn)方法變更,修訂后的檢驗(yàn)方法保持相同的方法,具有等效性或更好保證原料藥或藥品所申明的鑒別、劑量、質(zhì)量、純度或效價(jià)方面的特性,或其可接受標(biāo)準(zhǔn)保持不變(例如,改變HPLC方法的流速或樣品溶液配制)
4.4 Replacement of a nonspecific identity test with a discriminating identity test that includes a change in acceptance criteria(e.g., replacing SDS-PAGE[11] with peptide map).采用一個(gè)有專屬性的鑒別取代一個(gè)非專屬性的鑒別,導(dǎo)致可接受標(biāo)準(zhǔn)變更(例如,用肽圖替代SDS-PAGE,見注11)4.5 Addition of an in-process test.增加中控檢驗(yàn)
4.6 Replacement of blend uniformity and in-process homogeneity tests with other appropriate testing that assures adequacy of mix.采用另一適當(dāng)?shù)?,可以保證混合充分性的檢測,替代現(xiàn)有混合均一性和中控均一性檢測。
4.7 Revision of tablet hardness if there is no significant change in the dissolution profile.不顯著改變?nèi)艹龆冉Y(jié)果的情況下,改變片劑硬度
4.8 Elimination of an in-process disintegration test where a dissolution test is required for release.放行包括溶出度檢測的情況下,取消中控的崩解測試
4.9 Deletion of the homogeneity test as a routine test from the application, provided the applicant has process controls in place to demonstrate the product’s homogeneity.申請者有過程控制證明產(chǎn)品均一性時(shí),刪除包括在注冊資料中日常均一性檢測
4.10 Addition of a test for packaging material to provide increased assurance of quality.對包裝材料增加檢測,以提高質(zhì)量保證
4.11 Tightening of an existing acceptance criterion.加嚴(yán)格已有的可接受標(biāo)準(zhǔn) Container/Closure System 密封/包裝系統(tǒng)
5.1 A change in the container/closure system for the storage of a nonsterile drug substance when the proposed container/closure system has no increased risk of leachable substances in the extractable profile(for liquids)and equivalent protection properties.對無菌原料藥用于存貯的密封/包裝系統(tǒng)進(jìn)行變更,提出的變更不增加浸出物風(fēng)險(xiǎn),沒有新增可萃取物質(zhì),具有相等的保護(hù)特性。
5.2 Use of a contract manufacturing organization(CMO)for the washing of a drug product stopper, provided the applicant certifies that the CMO’s washing process has been validated and the CMO’s site has been audited by the applicant(or by another party sponsored by the applicant)and found CGMP compliant.采用一個(gè)合同生產(chǎn)組織(CMO)清洗藥品瓶塞,已提供申請人執(zhí)照,CMO的清潔過程已經(jīng)過驗(yàn)證,CMO的工廠已經(jīng)過申請人(或由申請人指定的另一方)審計(jì),確認(rèn)符合CGMP要求。
5.3 For solid oral dosage forms: 對于固體口服制劑
5.3.1 Elimination of bottle dunnage.去除瓶上手提裝置 5.3.2 Change in type of desiccant to another equivalent desiccant that was previously used in another approved product.將干燥劑改為在另一已批準(zhǔn)的產(chǎn)品中使用的另一同等能力的干燥劑
5.4 For parenteral drug products, a change in glass supplier without a change in glass type or coating and without a change in container/closure dimensions.對于非口服藥品,在不改變玻璃瓶種類和涂層及尺寸的情況下變更供應(yīng)商。
5.5 Changes to a crimp cap(ferrule and cap/overseal), provided that there are no changes to the labeling or the color and that container and closure integrity have been demonstrated using a validated test method.對密封蓋(套金屬和蓋/密封),如果標(biāo)識方式無變化,顏色、整體密封包裝形式經(jīng)驗(yàn)證過的檢驗(yàn)方法證明無變化。Miscellaneous Changes 其它變更
6.1 Extension of expiry based on real-time stability data from pilot scale batches following an approved stability protocol.根據(jù)已批準(zhǔn)的穩(wěn)定性試驗(yàn)方案,基于中試規(guī)模進(jìn)行的實(shí)時(shí)穩(wěn)定性試驗(yàn)數(shù)據(jù)延長有效期
6.2 Reduction of expiration dating for a drug product for reasons other than stability failures.由于非穩(wěn)定性失敗的原因縮短藥品有效期
6.3 If a dissolution test is performed, elimination of a nonstability indicating test for identity or hardness from an approved stability protocol.在進(jìn)行溶出度試驗(yàn)前提下,將鑒別或硬度非穩(wěn)定性指示試驗(yàn)從已批準(zhǔn)的穩(wěn)定性試驗(yàn)方案中刪除
6.4 For changes in an application that are fully consistent in scope and requirements with changes previously approved in a bundled supplement, the same applicant can add similar drug products.(See MAPP 5015.6, “Review of the Same Supplemental Change to More than One NDA or ANDA in More Than One Review Division”
在對一個(gè)與之前已批準(zhǔn)的組合增補(bǔ)的范圍和要求完全一致的申請進(jìn)行變更時(shí),同一申請人可以增加類似的藥品(見MAPP 5015.6“對需多部門審核的多個(gè)NDA或ANDA的相同增補(bǔ)的審核”)
[1] This guidance has been prepared by the Office of Pharmaceutical Science(OPS)in the Center for Drug Evaluation and Research(CDER)at the Food and Drug Administration.[2] See 21 CFR 314.70(d).[3] This guidance excludes positron emission tomography(PET)drug products.See the guidance for industry, PET Drugs — Current Good Manufacturing Practice(CGMP).[4] Public Law 105-115.[5] CDER updates guidances periodically.To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at www.tmdps.cnplianceRegulatoryInformation/Guidances/default.htm.[6] Note that the guidance, Changes to an Approved NDA or ANDA, will be revised to reflect these recommendations.注意該指南“已批準(zhǔn)的NDA或ANDA的變更”將進(jìn)行修訂以反映這些建議。[7] Under 21 CFR 314.70(a)(3), an applicant is required to make a change in accordance with a regulation or guidance that provides for a less burdensome notification of the change, but in this guidance we are asking sponsors to use judgment in determining which changes should be submitted in a prior approval supplement.根據(jù)21CFR 314.70(a)(3),申請人應(yīng)根據(jù)較少繁雜的法規(guī)或指南進(jìn)行變更,但在本指南中,我們要求申請人進(jìn)行判定,哪一種變更需要進(jìn)行預(yù)批準(zhǔn)增補(bǔ)。
[8] See 21 CFR 210 and 211.[9] See 21 CFR 314.81(b)(2)(i).[10] See the Inactive Ingredient Guide, available on FDA’s web site at 參見活性成分指南,可以以下網(wǎng)站找到www.accessdata.fda.gov/scripts/cder/iig/index.cfm.[11] SDS-PAGE stands for sodium dodecyl sulphate polyacrylamide gel electrophoresis.
第二篇:外商投資企業(yè)注冊登記指南(中英文對照)(本站推薦)
Guidance on Registration
Documents(one copy for each)for name approval application of foreign(including Hong Kong, Taiwan and Macao)invested enterprises 1.The “application for name pre-approval of foreign invested enterprises” signed by all investors;全體投資人簽署的《外商投資企業(yè)名稱預(yù)先核準(zhǔn)申請書》;
2.Photocopies of qualification certificates of all investors;全體投資人的資格證明復(fù)印件; 3.Other relevant documents and certificates;其他有關(guān)文件、證件;
Documents for registration of establishment of a Foreign-, Hong Kong-, Macao-or Taiwan-Invested enterprise(one copy for each)
For registration of establishment of a Foreign-Invested company
1、“The establishment registration application Form for foreign invested Enterprises” by the legal representative to be appointed 擬任法定代表人簽署的《外商投資的公司設(shè)立登記申請書》
2、The approval document issued by the approval authority(one duplicate of official reply and approval certificate);審批機(jī)關(guān)的批準(zhǔn)文件(批復(fù)和批準(zhǔn)證書副本1)
3、Articles of association公司章程
4、The notification of name pre-approval 《名稱預(yù)先核準(zhǔn)通知書》
5、Proof of subject qualification or proof of identification as a natural person for investors 投資者的主體資格證明或自然人身份證明
6、Photocopies of documents of appointment and proof of identification for directors, supervisors and managers董事、監(jiān)事和經(jīng)理的任職文件及身份證明復(fù)印件
7、Photocopies of documents of appointment and proof of identification for legal representative法定代表人任職文件和身份證明復(fù)印件
8、Investment verification certificates issued by a legally established investment verification authority依法設(shè)立的驗(yàn)資機(jī)構(gòu)出具的驗(yàn)資證明
9、Where a shareholder has made his/her capital contribution with nom-currency properties for the first time, documents proving the completion of property transfer procedures shall be submitted.股東首次出資是非貨幣財(cái)產(chǎn)的,提交已辦理財(cái)產(chǎn)權(quán)轉(zhuǎn)移手續(xù)的證明文件
10、Certificate of company domicile公司住所證明
11、The minutes of the inaugural assembly;創(chuàng)立大會(huì)的會(huì)議記錄
12、Pre-approval document or certificate;前置審批文件或證件
13、Letter of authorization for service of legal documents 法律文件送達(dá)授權(quán)委托書
14、Other relevant documents and certificates;其它有關(guān)文件
For registration of establishment of a Foreign-Invested enterprise(non-company)
1、“The application from signed by the pending legal representative”;擬任法定代表人簽署的《(非公司)外商投資企業(yè)設(shè)立登記申請書》
2、The approval document issued by the approval authority(one duplicate of official reply and approval certificate);審批機(jī)關(guān)的批準(zhǔn)文件(批復(fù)和批準(zhǔn)證書副本1)
3、Contract and articles of association;合同、章程
4、“The notification of name pre-approval” 名稱預(yù)先核準(zhǔn)通知書
5、Investor's legal business certificate and credit certificate;投資者的合法開業(yè)證明和資信證明
6、Photocopies of documents of appointment and proof of identification for legal representative and members of Joint management committee法定代表人、聯(lián)合管理委員會(huì)委員任職文件原件及身份證明復(fù)印件
7、The certificate of using the new domicile;住所使用證明
8、Investment verification certificates issued by a legally established investment verification authority依法設(shè)立的驗(yàn)資機(jī)構(gòu)出具的驗(yàn)資證明
9、Pre-approval document or certificate;前置審批文件或證件
10、Other relevant documents and certificates;其它有關(guān)文件
For registration of cancellation of a Foreign-Invested company
1、“The cancellation registration application form for foreign invested enterprises” signed by the responsible person of the liquidation team 清算組負(fù)責(zé)人簽署的《外商投資的公司注銷登記申請書》
2、The approval document issued by the original approval authority agreeing the cancellation;原審批機(jī)關(guān)同意注銷的批準(zhǔn)文件
3、Resolution or decision made in accordance with laws依法作出的決議或者決定
4、Liquidation report that has been recorded and confirmed in accordance with laws經(jīng)依法備案、確認(rèn)的清算報(bào)告
5、Certificate for registration of cancellation issued by taxation and customs authorities稅務(wù)和海關(guān)部門出具的完稅證明
6、Certificate for registration of cancellation of branches分公司的注銷登記證明
7、The original and the duplicate business license營業(yè)執(zhí)照正、副本
8、Other relevant documents and certificates;其它有關(guān)文件
For registration of cancellation of a Foreign-Invested enterprise(non-company)
1、“The cancellation registration application form for foreign invested enterprises”;
2、The approval document issued by the original approval authority agreeing the cancellation;
3、Resolution or decision made in accordance with laws
4、Reports confirming the settlement of credits and liabilities or documents formulated by liquidation team that are responsible for settlement of credits and liabilities
5、Duty-paid certificates issued by taxation authority and customs;
6、Certificates showing cancellation of its branches(administrative offices);
7、The original and the duplicate business license, as well as the official stamp
8、Other relevant documents and certificates 《外商投資企業(yè)注銷登記申請書》
2、原審批機(jī)關(guān)同意注銷的批準(zhǔn)文件
3、依法作出的決議或決定
4、清理債權(quán)債務(wù)完結(jié)的報(bào)告或者清算組織負(fù)責(zé)清理債權(quán)債務(wù)的文件
5、稅務(wù)和海關(guān)出具的完稅證明
6、分支(辦事)機(jī)構(gòu)已注銷的證明
7、營業(yè)執(zhí)照正、副本和公章
8、其它有關(guān)文件
Cancellation of modification registration of foreign invested enterprises 1.“Application Form for Cancellation of Modification Registration of Foreign Invested Enterprises” signed by the legal representative of the company;2.Written judgment of the people's court;
3.The former approval letter for the application of modification registration;4.Photocopy of the duplicate of the business license;5.Other relevant documents;
The modification(for record)registration application form for foreign invested enterprises
Modification of company name
1、“The modification(for record)registration application form for foreign invested enterprises”;
2、Resolution or decision made in accordance with laws
3、The photocopy of the duplicate of the business license
4、The notification of name pre-approval;
5、The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;
6、Other relevant documents;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、依法作出的決議或決定
3、營業(yè)執(zhí)照副本復(fù)印件
4、名稱變更核準(zhǔn)通知書
5、公司法定代表人簽署的公司章程修正案或修改后的公司章程
6、其他有關(guān)文件
Modification of company domicile 1.“The modification(for record)registration application form for foreign invested enterprises”;
2、Resolution or decision made in accordance with laws
3、The Amendment of Articles of Association or the Revised Articles of Association signed by the legal representative
4、The certificate of using the new domicile;
5、The photocopy of the duplicate of the business license
6、Other relevant documents;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、依法作出的決議或決定
3、公司法定代表人簽署的公司章程修正案或修改后的公司章程
4、住所使用證明
5、營業(yè)執(zhí)照副本復(fù)印件
6、其他有關(guān)文件
Modification of the legal representative
1、“The modification(for record)registration application form for foreign invested enterprises”;
2、Resolution or decision made in accordance with laws
3、The appointment document of the new legal representative and the dismissal document of the former legal representative;
4、The registration form of the new legal representative;
5、The photocopy of the duplicate of the business license
6、The approval document issued by the approval authority;
7、Other relevant documents;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、依法作出的決議或決定
3、原法定代表人的免職文件和新任法定代表人的任職文件
4、新任法定代表人登記表
5、營業(yè)執(zhí)照副本復(fù)印件
6、審批機(jī)關(guān)的批準(zhǔn)文件
7、其它有關(guān)文件
Modification of gross investment and registered capital
1.“The modification(for record)registration application form for foreign invested enterprises”;2.Approval document and certificate issued by the approval authority(one duplicate);
3、Resolution or decision made in accordance with laws
4、The modification agreement for contract and articles of association;
5、The Amendment of Articles of Association or the Revised Articles of Association signed by the legal representative
6、Investment verification certificates issued by a legally established investment verification authority
7、Sample newspaper that publishes the capital reduction announcement and debt repayment report or debt assurance certificate
8、The photocopy of the duplicate of the business license
9、Other relevant documents;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、審批機(jī)關(guān)的批準(zhǔn)文件(批復(fù)和批準(zhǔn)證書副本1)
3、依法作出的決議或決定
4、合同、章程的修改協(xié)議
5、公司法定代表人簽署的公司章程修正案或修改后的公司章程
6、依法設(shè)立的驗(yàn)資機(jī)構(gòu)出具的驗(yàn)資證明
7、刊登減資公告的報(bào)紙報(bào)樣及債務(wù)清償報(bào)告或債務(wù)擔(dān)保證明
8、營業(yè)執(zhí)照副本復(fù)印件
9、其它有關(guān)文件
Modification of the paid-in registered capital 1.“The modification(for record)registration application form for foreign invested enterprises”;
2.Certificate of investment verification issued by an investment verification entity established according to the law;
3.Photocopy of the duplicate of the business license;4.Other relevant documents;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、依法設(shè)立的驗(yàn)資機(jī)構(gòu)出具的驗(yàn)資證明
3、營業(yè)執(zhí)照副本復(fù)印件
4、其它有關(guān)文件
Modification of time and forms of investment(new investment)
1.“The Modification(for record)Registration Application Form for Foreign Invested Enterprises” signed by the legal representative of the company;
2.Approval document issued by the approval authority(one duplicate of the official reply and the approval certificate);
3.Resolution or decision made according to the law;
4.The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;5.Photocopy of the duplicate of the business license;6.Other relevant documents;
1、公司法定代表人簽署的《外商投資的公司變更(備案)登記申請書》
2、審批機(jī)關(guān)的批準(zhǔn)文件(批復(fù)和批準(zhǔn)證書副本1)
3、依法作出的決議或決定
4、公司法定代表人簽署的公司章程修正案或修改后的公司章程
5、營業(yè)執(zhí)照副本復(fù)印件
6、其它有關(guān)文件
Modification of business period
1.“The modification(for record)registration application form for foreign invested enterprises”;
2.Approval document and certificate issued by the approval authority(one duplicate);
3、Resolution or decision made in accordance with laws 4.The modification agreement for contract and articles of association;
5、The Amendment of Articles of Association or the Revised Articles of Association signed by the legal representative
6、The photocopy of the duplicate of the business license
7、Other relevant documents;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、審批機(jī)關(guān)的批準(zhǔn)文件(批復(fù)和批準(zhǔn)證書副本1)
3、依法作出的決議或決定
4、合同、章程的修改協(xié)議
5、公司法定代表人簽署的公司章程修正案或修改后的公司章程
6、營業(yè)執(zhí)照副本復(fù)印件
7、其它有關(guān)文件
Modification of business scope 1.1.“The modification(for record)registration application form for foreign invested enterprises”;
2.Approval document issued by the approval authority(one duplicate of the official reply and the approval certificate);
3.Resolution or decision made according to the law;
4.The modification agreement for contract and articles of association;
5.The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;6.Photocopy of the duplicate of the business license;7.Prior approval documents or certificates;8.Other relevant documents;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、審批機(jī)關(guān)的批準(zhǔn)文件(批復(fù)和批準(zhǔn)證書副本1)
3、依法作出的決議或決定
4、合同、章程的修改協(xié)議
5、公司法定代表人簽署的公司章程修正案或修改后的公司章程
6、營業(yè)執(zhí)照副本復(fù)印件
7、前置審批文件或證件
8、其他有關(guān)文件
Modification of share ownership
1、“The modification(for record)registration application form for foreign invested enterprises”;
2、Approval document and certificate issued by the approval authority(one duplicate);
3、Resolution or decision made according to the law;
4、The modification agreement for contract and articles of association;
5、The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;
6、The share transfer agreement;
7、Statement acquiring the approval of other investors to allow the transfer in accordance with laws
8、The proof of subject qualification of the transferee;
9、Certificate of financial standing of the transferee;
10、Letter of attorney for the serving of legal documents;
11、The photocopy of the duplicate of the business license
12、Other relevant documents;
1、外商投資企業(yè)變更(備案)登記申請書
2、審批機(jī)關(guān)的批準(zhǔn)文件(批復(fù)和批準(zhǔn)證書副本1)
3、依法作出的決議或決定
4、合同、章程的修改協(xié)議
5、公司法定代表人簽署的公司章程修正案或修改后的公司章程
6、股權(quán)轉(zhuǎn)讓協(xié)議
7、依法經(jīng)其他投資方同意轉(zhuǎn)讓的聲明
8、股權(quán)受讓方的主體資格證明
9、股權(quán)受讓方的資信證明
10、法律文件送達(dá)授權(quán)委托書
11、營業(yè)執(zhí)照副本復(fù)印件
12、其它有關(guān)文件
Modification of investor name
1.“The modification(for record)registration application form for foreign invested enterprises”;
2.Approval document issued by the approval authority(one duplicate of the official reply and the approval certificate);
3.Evidentiary documents for modification of investor name;
4.The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;5.Photocopy of the duplicate of the business license;6.Other relevant documents;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、審批機(jī)關(guān)的批準(zhǔn)文件(批復(fù)和批準(zhǔn)證書副本1)
3、投資者名稱變更的證明文件
4、公司法定代表人簽署的公司章程修正案或修改后的公司章程
5、營業(yè)執(zhí)照副本復(fù)印件
6、其它有關(guān)文件
The registration form for company form modification 1.“The Modification(for record)Registration Application Form for Foreign Invested Enterprises” signed by the legal representative of the company;Invested Enterprises“ signed by the legal representative of the company;2.Approval document issued by the approval authority(one duplicate of the official reply and the approval certificate);
3.Resolution or decision made according to the law;
4.The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;5.Photocopy of the duplicate of the business license;6.Other relevant documents;
1、公司法定代表人簽署的《外商投資企業(yè)變更(備案)登記申請書》
2、審批機(jī)關(guān)的批準(zhǔn)文件(批復(fù)和批準(zhǔn)證書副本1)
3、依法作出的決議或決定
4、公司法定代表人簽署的公司章程修正案或修改后的公司章程
5、營業(yè)執(zhí)照副本復(fù)印件
6、其它有關(guān)文件
Increase branches 1.”The modification(for record)registration application form for foreign invested enterprises“;
2.Resolution made according to the law;
3.The approval document issued by the approval authority;4.Photocopy of the business license;5.Other relevant documents;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、依法作出的決議
3、審批機(jī)關(guān)的批準(zhǔn)文件
4、營業(yè)執(zhí)照復(fù)印件
5、其它有關(guān)文件
Disband branches 1.”The modification(for record)registration application form for foreign invested enterprises“;2.Resolution or decision made according to the law;
3.The approval document issued by the approval authority;4.The cancellation certificate issued by the registration authority of the branch(administrative office);5.Photocopy of the duplicate of the business license;6.Other relevant documents and certificates;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、依法作出的決議或決定
3、審批機(jī)關(guān)的批準(zhǔn)文件
4、分支(辦事)機(jī)構(gòu)登記機(jī)關(guān)出具的注銷證明
5、營業(yè)執(zhí)照副本復(fù)印件
6、其它有關(guān)文件、證件
Put the director(supervisor)on record 1.”The modification(for record)registration application form for foreign invested enterprises“;
2.The dismissal document of the former director, supervisor or manager and the appointment document and photocopy of identification paper of the new director, supervisor or manager;
3.The dismissal documents of former members of the Joint Management
Committee and the appointment documents and photocopies of identification papers of new members of the Joint Management Committee;
4.”Basic information of the director, supervisor or manager/members of the Joint Management Committee“;
5.Photocopy of the duplicate of the business license;6.Other relevant documents;
1、《外商投資企業(yè)變更(備案)登記申請書》
2、原董事、監(jiān)事、經(jīng)理的免職文件和新任董事、監(jiān)事、經(jīng)理的任職文件及身份證明復(fù)印件
3、原聯(lián)合管理委員會(huì)委員的免職文件和新任聯(lián)合管理委員會(huì)委員的任職文件及身份證明復(fù)印件
4、《董事、監(jiān)事、經(jīng)理/聯(lián)合管理委員會(huì)委員情況表》
5、營業(yè)執(zhí)照副本復(fù)印件
6、其它有關(guān)文件
Put other items on record 1.Stock equity hypothecation:
A.”The modification(for record)registration application form for foreign invested enterprises“;
B.Approval document of the approval authority;
C.Resolution or decision made according to the law;
D.The legal hypothecation contract agreed by other investors;
E.Photocopy of the duplicate of the business license;股權(quán)質(zhì)押:
a.《外商投資企業(yè)變更(備案)登記申請書》
b.審批機(jī)關(guān)批準(zhǔn)文件
c.依法做出的決議或決定
d.依法經(jīng)其他投資方同意的質(zhì)押合同
e.營業(yè)執(zhí)照副本復(fù)印件
2.Branch company:
A.”The modification(for record)registration application form for foreign invested enterprises“;
B.Photocopy of the duplicate of the branch company's business license;
C.Photocopy of the duplicate of the company's business license;
D.Others 分公司:
a.《外商投資企業(yè)變更(備案)登記申請書》
b.分公司營業(yè)執(zhí)照副本的復(fù)印件
c.公司營業(yè)執(zhí)照副本的復(fù)印件
d.其他材料
3.Members or chief of the liquidation team:
A.”The modification(for record)registration application form for foreign invested enterprises“ signed by the chief of the company's liquidation team;
B.Resolution or decision made according to the law;
C.Photocopy of the duplicate of the business license;
D.Others 清算組成員清算組負(fù)責(zé)人:
a.公司清算組負(fù)責(zé)人簽署的《外商投資企業(yè)變更(備案)登記申請書》
b.依法做出的決議或決定
c.營業(yè)執(zhí)照副本復(fù)印件d.其他材料
4.Modification of the articles of association that does not relate to the registered items:
A.”The modification(for record)registration application form for foreign invested enterprises“;
B.The approval document issued by the approval authority;
C.The amendment to the Articles of Association or the revised Articles of Association signed by the legal representative of the company;
D.Photocopy of the duplicate of the business license;不涉及登記事項(xiàng)的章程修改:
a.《外商投資企業(yè)變更(備案)登記申請書》
b.審批機(jī)關(guān)的批準(zhǔn)文件
c.公司法定代表人簽署的公司章程修正案或修改后的公司章程
d.營業(yè)執(zhí)照副本復(fù)印件
5.Overseas shareholder, founder or recipient of legal documents:
A.”The modification(for record)registration application form for foreign invested enterprises“;
B.”Letter of attorney for the serving of legal documents“;
C.Photocopy of the proof of subject qualification of the authorized person;境外股東、發(fā)起人法律文件送達(dá)接受人:
a.《外商投資企業(yè)變更(備案)登記申請書》
b.《法律文件送達(dá)授權(quán)委托書》
c.被授權(quán)人的主體資格證明復(fù)印件
6.Contact person for industrial and commercial registration
A.”The modification(for record)registration application form for foreign invested enterprises";
B.Basic information of the contact person for industrial and commercial registration
工商登記聯(lián)絡(luò)員:
a.《外商投資企業(yè)變更(備案)登記申請書》
b.工商登記聯(lián)絡(luò)員基本情況
第三篇:FDA發(fā)布可以通過年報(bào)報(bào)告的批準(zhǔn)后生產(chǎn)變更指南
CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports
可以通過年報(bào)報(bào)告的批準(zhǔn)后生產(chǎn)變更
源網(wǎng)址:http://www.tmdps.cnplianceRegulatoryInformation/Guidances/UCM217043.pdf
日期:2014.3
類型:生效
摘要:本指南的目的旨在為NDA和ANDA申請者提供一些建議,關(guān)于哪些類型的變更可以通過年報(bào)來報(bào)告,需要注意的是,本指南中所提到的關(guān)于化學(xué),生產(chǎn)和控制(CMC)的批準(zhǔn)后變更是指已經(jīng)明確了對產(chǎn)品質(zhì)量本身幾乎不會(huì)產(chǎn)生不良反應(yīng)的變更,因此,可以通過年報(bào)報(bào)告。
內(nèi)容簡報(bào):該指南的主要內(nèi)容如下:
申請者需根據(jù)法規(guī)要求將產(chǎn)品批準(zhǔn)后的變更告知FDA。根據(jù)21CFR314.70,對于NDA和ANDA,所有的CMC批準(zhǔn)后的變更分為三類:大變更(major),中等變更(moderate)和小變更(minor)。對于大變更,NDA和ANDA申請者必須向FDA遞交補(bǔ)充申請(也稱為PAS)并要求在得到批準(zhǔn)后方能實(shí)施變更。若變更被認(rèn)為是中等變更,申請者必須在產(chǎn)品分銷前至少30天提交補(bǔ)充申請(CBE-30 supplement),在某些情況下可以在分銷時(shí)遞交補(bǔ)充申請(CBE-0 supplement)。如果某個(gè)變更認(rèn)為是小變更,申請者可以自行執(zhí)行此變更,但需要通過年報(bào)告知FDA。對于任何一種變更,申請都需要評估其對于產(chǎn)品質(zhì)量的影響。
近年來NDA和ANDA遞交的CMC生產(chǎn)補(bǔ)充申請?jiān)絹碓蕉?。FDA在評估了很多批準(zhǔn)后變更申請后認(rèn)為許多報(bào)告的變更對產(chǎn)品本身的質(zhì)量影響的風(fēng)險(xiǎn)很低,認(rèn)為這些變更不需要以批準(zhǔn)后變更(PAS)的方式遞交。
基于風(fēng)險(xiǎn)評估的基礎(chǔ),F(xiàn)DA提供了一個(gè)清單(見附件A),其中列舉了一些對于產(chǎn)品質(zhì)量產(chǎn)生不良反應(yīng)的風(fēng)險(xiǎn)較低的例子,對于此類變更不需要遞交補(bǔ)充申請(PAS),可以執(zhí)行后在下一年的年報(bào)中體現(xiàn)。
列在附件A中的變更是根據(jù)生產(chǎn)變更的種類來分類的。這些變更是對SUPAC指南或其他相關(guān)指南中提到的需在年報(bào)中報(bào)告的變更的修訂或補(bǔ)充。因此在基于此前的指南來遞交補(bǔ)充申請前有必要參考一下本指南附件A中提到建議。
我們希望NDA或者ANDA申請者在提交申請前能以書面的形式來評估變更對產(chǎn)品質(zhì)量是否存在不良反應(yīng)。若評估結(jié)果表明此變更對產(chǎn)品質(zhì)量影響很小,那么變更可以在下一年的年報(bào)中體現(xiàn)。當(dāng)然,NDA或者ANDA申請者也可以根據(jù)產(chǎn)品實(shí)際的情況來決定,附件A或B中列舉的變更可能通過補(bǔ)充申請(PAS)的途徑來報(bào)告更合適。在這種情況下,應(yīng)該根據(jù)風(fēng)險(xiǎn)評估的結(jié)果和21CFR 314.70的要求來報(bào)告變更給當(dāng)藥政當(dāng)局。因此,本指南的目的是對能在年報(bào)中報(bào)告的變更提出一些建議,而非強(qiáng)制此類變更必須按照21CFR 314.70以年報(bào)形式報(bào)告。
對于在本指南中沒有提到的變更,或者其他多個(gè)同時(shí)執(zhí)行的相關(guān)的變更,申請者可以參考其他CDER指南(見第四部分)或附件B來決定合適的報(bào)告種類(e.g.PAS, CBE-30, CBE-0或者年報(bào))。
需要注意的是,對于活性成分的生產(chǎn)請參考Q7A。成品的CGMP法規(guī)中包含的一些與變更種類有關(guān)的特定要求都在本指南中有提到。無論是以哪種形式來報(bào)告的變更都必須要符合CGMP。CGMP法規(guī)包括建立并符合相應(yīng)的書面文件,并且該文件需要經(jīng)過質(zhì)量控制部分的審核和批準(zhǔn),設(shè)備是合格可用的,方法需要經(jīng)過驗(yàn)證,商業(yè)生產(chǎn)工藝是建立在科學(xué)基礎(chǔ)上,確保生產(chǎn)工藝過程可控(根據(jù)變更的情況可能需要進(jìn)行額外的工藝驗(yàn)證和穩(wěn)定性研究。)。
對于以年報(bào)形式報(bào)告的變更,申請者需對CMC變更進(jìn)行詳細(xì)的闡述來表明此變更不需要以補(bǔ)充申請(PAS)的形式遞交,闡述的內(nèi)容包括:
? 以清單的形式列舉每個(gè)變更和相應(yīng)的執(zhí)行日期,以及
? 評估產(chǎn)品質(zhì)量影響的研究數(shù)據(jù)匯總表,如變更控制的交叉索引清單和變更驗(yàn)證方案,以及用于評估變更影響的SOP 還應(yīng)包括:
? 在變更中受到影響的一個(gè)或多個(gè)產(chǎn)品名(不同規(guī)格和產(chǎn)品)或者,? 如果變更影響到多個(gè)產(chǎn)品,索引到任何之前已經(jīng)批準(zhǔn)的“grouped supplements”(指變更影響到多個(gè)產(chǎn)品,其中的某些產(chǎn)品已經(jīng)遞交過變更)
批記錄,SOP和用于評估每種變更的研究數(shù)據(jù)以及檢測都應(yīng)該存檔以便官方查看(如現(xiàn)場檢查時(shí))。申請者應(yīng)該在年報(bào)中盡可能詳細(xì)的描述每種變更,這樣有利于官方判斷變更的分類是否正確。如果遞交的變更不適合在年報(bào)中報(bào)告,申請者將會(huì)被通知以正確的分類來遞交或者補(bǔ)充額外信息。附件A 通過年報(bào)報(bào)告的對產(chǎn)品質(zhì)量產(chǎn)生不良反應(yīng)風(fēng)險(xiǎn)較小的CMC變更實(shí)例
1.組成和成分
除去或減少制劑產(chǎn)品生產(chǎn)中處方中的過量投料,該過量本來的目的是為了補(bǔ)償生產(chǎn)過程中的損失。
固體速釋制劑的包衣成分的改變,前提是該包衣材料的用量已經(jīng)被其他相似的已獲批產(chǎn)品使用過,并且該變更不會(huì)改變藥物的釋放或者質(zhì)量標(biāo)準(zhǔn)(如檢測項(xiàng),分析方法或可接受標(biāo)準(zhǔn)),或者穩(wěn)定性。
非活性成分供應(yīng)商變更(如,從一個(gè)DMF holder更換成另一個(gè)DMF holder,或者換成新的合格的供應(yīng)商),這種變更的前提是非活性物質(zhì)的質(zhì)量標(biāo)準(zhǔn)不發(fā)生改變。
2.生產(chǎn)地址
已經(jīng)被批準(zhǔn)的無菌制劑廠進(jìn)行微小結(jié)構(gòu)改造,前提是該變更不會(huì)影響產(chǎn)品生產(chǎn)區(qū)或無菌保障,也不會(huì)改變產(chǎn)品的質(zhì)量或者質(zhì)量標(biāo)準(zhǔn)。
在生產(chǎn)無菌產(chǎn)品時(shí),在傳統(tǒng)填充區(qū)增加屏障,以防止IPC人員干擾經(jīng)過驗(yàn)證的合格的填充區(qū)。
3.生產(chǎn)工藝,批量和設(shè)備:
以下工藝發(fā)生改變:
在非無菌條件下增加過篩的步驟用以除掉團(tuán)塊。
變更速釋口服固體制劑或液體制劑的混合時(shí)間(用于混合粉末或顆粒)
變更速釋固體口服制劑的干燥時(shí)間
生產(chǎn)批量的改變,這個(gè)改變是由將幾個(gè)單獨(dú)亞批的中間物料混合后引起的。前提是所有混合后的批次都滿足已批準(zhǔn)的IPC標(biāo)準(zhǔn),并且混合后的下一工序不會(huì)受到影響,生產(chǎn)過程可追溯。
無菌生產(chǎn)工藝中的設(shè)備發(fā)生改變(如新灌裝線,新凍干機(jī)),當(dāng)不改變已批準(zhǔn)的工藝和IPC標(biāo)準(zhǔn)時(shí),新設(shè)備的設(shè)計(jì)和操作原理必須與之前的設(shè)備一樣。
增加相同的工藝線,以便于原料藥和制劑生產(chǎn)工藝過程中可以平行操作,必須保證對IPC限度或產(chǎn)品質(zhì)量標(biāo)準(zhǔn)無影響。
對于無菌產(chǎn)品,可以增加,減少或者改變再過濾的再加工的方案,以解決由于濾膜完整性測試失敗而引起的生物負(fù)載的問題
可以減少開放性處理步驟的次數(shù)或者人工操作步驟來降低產(chǎn)品的風(fēng)險(xiǎn),但不能改變其他工藝(如采用無菌連接設(shè)備來取代火焰保護(hù)程序)
對于無菌產(chǎn)品,在已經(jīng)驗(yàn)證的參數(shù)范圍內(nèi)變更過濾工藝參數(shù)的范圍(如流速,壓力,時(shí)間或者體積,但不改變孔徑),不需要對新范圍再進(jìn)行驗(yàn)證。
在生產(chǎn)無菌產(chǎn)品時(shí),將某一合格的消毒室(環(huán)氧乙烷,高壓滅菌器)變更為另一相同設(shè)計(jì)和操作原理的無菌室用于制備包裝系統(tǒng),工藝設(shè)備的“變更的零件”的滅菌和產(chǎn)品的終端滅菌,前提是新的操作室和裝載配置是經(jīng)過驗(yàn)證并在之前的驗(yàn)證參數(shù)內(nèi)。變更驗(yàn)證參數(shù)不屬于此情況。
4.質(zhì)量標(biāo)準(zhǔn)
在輔料質(zhì)量標(biāo)準(zhǔn)中增加新的檢測項(xiàng) 變更原料藥,制劑產(chǎn)品或藥典輔料的質(zhì)量標(biāo)準(zhǔn),使其符合藥典標(biāo)準(zhǔn)。前提是該變更不會(huì)放寬可接受標(biāo)準(zhǔn)或者刪除某一檢測項(xiàng)。
不適合在年報(bào)中體現(xiàn)的質(zhì)量標(biāo)準(zhǔn)的變更包括已批準(zhǔn)NDAs或ANDAs中含量,雜質(zhì),降解產(chǎn)物,成品有關(guān)物質(zhì)或者生物活性檢測方法的變更。此類變更需要遞交補(bǔ)充申請(PAS)。
改變已批準(zhǔn)的分析方法,前提是修改的方法維持原有的方法學(xué)原理并對原料藥或制劑提供等價(jià)或更嚴(yán)格的保障。產(chǎn)品鑒別,規(guī)格,質(zhì)量,純度或效能等特性如其所要求不會(huì)發(fā)生改變,可接受標(biāo)準(zhǔn)不會(huì)改變(如改變HPLC方法中流速或者樣品制備方法)
取代某一非專屬性的鑒別方法,使其更具區(qū)分能力(新方法的可接受標(biāo)準(zhǔn)以范圍的形式表示)。
增加中控檢測
用其他更為合適的方法來取代混合均勻度或中間過程的均一性檢測來保證混合的充分性。
修訂片劑的硬度(如檢測結(jié)果的可接受標(biāo)準(zhǔn),或者改變不同的分析方法及相應(yīng)的可接受標(biāo)準(zhǔn)),前提是對已獲批的溶出分析方法,可接受標(biāo)準(zhǔn)或溶出曲線沒有影響。
增加包裝材料的檢測以提高產(chǎn)品質(zhì)量保障。
收窄已經(jīng)獲批的原料藥,制劑產(chǎn)品,制劑處方組成或中控物質(zhì)的可接受標(biāo)準(zhǔn)
5.容器/密閉系統(tǒng)
變更非無菌原料藥(固體,半固體或液體)的包裝系統(tǒng),前提是新的包裝系統(tǒng)在不會(huì)增加可萃取物質(zhì)(半固體或液體)的風(fēng)險(xiǎn),并能提供與之前的包裝材料等價(jià)的保護(hù)特性。
使用或者改變合同加工商(CMO)來清洗,干燥或者硅化產(chǎn)品的塞子或者包裝系統(tǒng)的某一部分,前提是申請者能證明CMO的工藝是經(jīng)過驗(yàn)證的或者CMO工廠通過了申請者(或者其他申請者贊助的團(tuán)體)的審計(jì)且符合CGMP的要求
對于固體口服制劑,改變某種一級包裝材料,該成分已被其他CDER已批準(zhǔn)的產(chǎn)品用過:
改變干燥劑的型號,該干燥劑已被其他獲批的產(chǎn)品使用且更適合本產(chǎn)品。
減少裝瓶的填充空間,如纖維材料(合適種類的棉花,人造纖維,聚酯等)可用于減少產(chǎn)品包裝中的空隙空間。
對于透皮制劑,變更玻璃供應(yīng)商但不改變玻璃的種類,涂層,也不改變包裝的尺寸。
變更螺旋蓋(套圈或翻蓋/頂封),前提是顏色不改變,并用驗(yàn)證過的方法來證明其包裝完整性。需要注意的是,如果翻蓋或者頂封顏色發(fā)生了改變需要確保其與已經(jīng)建立的顏色條形碼系統(tǒng)相符,產(chǎn)品級別需要在年報(bào)中闡明。
改變或去掉公司商標(biāo)或其他螺旋密封蓋上的標(biāo)記來符合藥典要求
6.標(biāo)簽變更
修訂產(chǎn)品標(biāo)簽來反應(yīng)包衣組成中非活性成分的定性變化,如以上1.2中所述。應(yīng)該在執(zhí)行此變更時(shí)把的變更的最終的產(chǎn)品標(biāo)簽(SPL)提交給藥政當(dāng)局。以便于在eLIST中更新現(xiàn)行的產(chǎn)品信息,這有助于確保產(chǎn)品使用的安全性和有效性。
通過變更產(chǎn)品標(biāo)簽來修訂CMC相關(guān)的變更信息在本指南中有討論。如果變更包含產(chǎn)品標(biāo)簽的修訂,6.1中提到內(nèi)容都將適用。
7.其他變更
根據(jù)已批準(zhǔn)的穩(wěn)定性方案,基于注冊批或者商業(yè)批的穩(wěn)定系數(shù)據(jù)來延長原料藥的復(fù)驗(yàn)期或制劑產(chǎn)品的有效期。
對于速釋固體制劑,如果進(jìn)行了溶出測試,可以從已批準(zhǔn)的穩(wěn)定性方案中去掉鑒別和硬度檢測。
根據(jù)一個(gè)已經(jīng)獲批的“grouped supplement”變更來對其他的相似產(chǎn)品進(jìn)行同樣的變更。附件B:FDA SUPAC-IR,SUPAC-MR,SUPAC-SS和已經(jīng)批準(zhǔn)的NDA和ANDA變更指南中提到的需要在年報(bào)中報(bào)告的變更實(shí)例
1.組成和組分
為了符合藥典的要求而做的任何變更,除了放寬可接受標(biāo)準(zhǔn)或者去掉某一檢測項(xiàng)(見21CFR 314.70(c)(2)(iii))
完全或部分去掉影響產(chǎn)品顏色,氣味或者香味的成分而不改變產(chǎn)品的質(zhì)量標(biāo)準(zhǔn)。需要注意的是去掉或改變顏色,氣味或香味可能影響產(chǎn)品的外觀或制劑的其他顯著的感官特性(可見外觀,味道,香味,氣味或者香氣)。這些變更可能會(huì)影響標(biāo)簽中“How the Drug Product is Supplied”的部分。在這種情況下,附件A中第6部分標(biāo)簽變更可適用。
變更非控釋輔料在處方中的用量,以占總處方組成百分比(w/w)的形式表示,與最初的申請相比變化不超過以下范圍:填充劑±5%,崩解劑(淀粉±3%,其他±1%),粘合劑±0.5%,潤滑劑(硬脂酸鈣或硬脂酸鎂±0.25%,其他±1%),助流劑(滑石粉±1%,其他±0.1%),包衣粉±1%。
變更輔料的供應(yīng)商,需要保證輔料的級別和質(zhì)量標(biāo)準(zhǔn)不改變
在控釋制劑中,任何一種控釋材料占總控制材料比例的改變,以百分比(w/w)的形式來表現(xiàn), 應(yīng)該小于或等于5%。變更后,制劑總片重和質(zhì)量標(biāo)準(zhǔn)應(yīng)該保持不變。
2.生產(chǎn)地址
如果新的生產(chǎn)地址通過CGMP的檢查,以下變更可以在年報(bào)中體現(xiàn):
變更固體制劑二級包裝,貼標(biāo)簽,油墨印字的地點(diǎn)或者原料藥中間體而非最后一步中間體的生產(chǎn)和加工地點(diǎn)
在同一個(gè)工廠內(nèi)變更生產(chǎn)地點(diǎn)(包括產(chǎn)品的終端滅菌),不管是單獨(dú)生產(chǎn)還是合作生產(chǎn)的工廠,不包括放大變更,生產(chǎn)工藝及設(shè)備的變更,產(chǎn)品組成和組分的變更。SOP,具備生產(chǎn)工藝經(jīng)驗(yàn)的操作人員,環(huán)境條件和控制,生產(chǎn)批記錄都保持不變,只有行政信息和同一個(gè)工廠的生產(chǎn)地點(diǎn)發(fā)生改變。3.生產(chǎn)工藝
對于藥品而言,可以變更具有相同設(shè)計(jì)和操作原理,容量,批量的設(shè)備(增加或減少),除天然蛋白質(zhì)原料藥和蛋白質(zhì)制劑以外。
可以變更液體制劑中組分的添加順序(除活性成分外)或者配制某單元操作中的溶液(如制粒液)時(shí),改變其組分添加順序
4.質(zhì)量標(biāo)準(zhǔn)
4.1.對于原料藥或者制劑成品,增加或者修訂某一可替換的分析方法,前提是要保證該分析方法與已經(jīng)獲批的分析方法相比,具有等效的或者更優(yōu)的鑒定,規(guī)格,質(zhì)量,純度,效能檢測方法。或者刪掉一個(gè)可替換的分析方法。
4.2 可以變更以下物質(zhì)的檢測方法,如原料藥合成中用到的原材料,在最終原料藥中間體之前引入的起始物料,最終中間體前的中控物料或原料藥中間體(不包括最終中間體),其前提是該分析方法與之前獲批的分析方法相比具有相同的或更優(yōu)的檢測能力。
第四篇:十八大報(bào)告中英文對照
政府工作報(bào)告
——2013年3月5日在第十二屆全國人民代表大會(huì)第一次會(huì)議上 國務(wù)院總理 溫家寶
REPORT ON THE WORK OF THE GOVERNMENT Delivered at the First Session of the Twelfth National People's Congress on March 5, 2013 Wen Jiabao, Premier of the State Council 各位代表:
現(xiàn)在,我代表國務(wù)院,向大會(huì)報(bào)告過去五年的政府工作,并對今年工作提出建議,請各位代表審議,并請全國政協(xié)委員提出意見。Fellow Deputies, On behalf of the State Council, I now present to you the report on the government's work of the past five years and suggestions for its work this year for your deliberation and for comments from the members of the National Committee of the Chinese People's Political Consultative Conference(CPPCC).一、過去五年工作回顧
I.Review of Work in the Past Five Years
第十一屆全國人民代表大會(huì)第一次會(huì)議以來的五年,是我國發(fā)展進(jìn)程中極不平凡的五年。我們有效應(yīng)對國際金融危機(jī)的嚴(yán)重沖擊,保持經(jīng)濟(jì)平穩(wěn)較快發(fā)展,國內(nèi)生產(chǎn)總值從26.6萬億元增加到51.9萬億元,躍升到世界第二位;公共財(cái)政收入從5.1萬億元增加到11.7萬億元;累計(jì)新增城鎮(zhèn)就業(yè)5870萬人,城鎮(zhèn)居民人均可支配收入和農(nóng)村居民人均純收入年均分別增長8.8%、9.9%;糧食產(chǎn)量實(shí)現(xiàn)“九連增”;重要領(lǐng)域改革取得新進(jìn)展,開放型經(jīng)濟(jì)達(dá)到新水平;創(chuàng)新型國家建設(shè)取得新成就,載人航天、探月工程、載人深潛、北斗衛(wèi)星導(dǎo)航系統(tǒng)、超級計(jì)算機(jī)、高速鐵路等實(shí)現(xiàn)重大突破,第一艘航母“遼寧艦”入列;成功舉辦北京奧運(yùn)會(huì)、殘奧會(huì)和上海世博會(huì);奪取抗擊汶川特大地震、玉樹強(qiáng)烈地震、舟曲特大山洪泥石流等嚴(yán)重自然災(zāi)害和災(zāi)后恢復(fù)重建重大勝利。我國社會(huì)生產(chǎn)力和綜合國力顯著提高,人民生活水平和社會(huì)保障水平顯著提高,國際地位和國際影響力顯著提高。我們圓滿完成“十一五”規(guī)劃,順利實(shí)施“十二五”規(guī)劃。社會(huì)主義經(jīng)濟(jì)建設(shè)、政治建設(shè)、文化建設(shè)、社會(huì)建設(shè)、生態(tài)文明建設(shè)取得重大進(jìn)展,譜寫了中國特色社會(huì)主義事業(yè)新篇章。
The past five years since the First Session of the Eleventh National People's Congress were a truly extraordinary period of time in the course of China's development.We effectively countered the severe impact of the global financial crisis and maintained steady and fast economic development.China's GDP increased from 26.6 trillion yuan to 51.9 trillion yuan, and now ranks second in the world.Government revenue went up from 5.1 trillion yuan to 11.7 trillion yuan.A total of 58.7 million urban jobs were created.The per capita disposable income of urban residents rose by an annual average of 8.8%, and the per capita net income of rural residents rose by 9.9%.Grain output increased for the ninth consecutive year in 2012.Progress was made in key areas of reform;and the open economy reached a new stage of development.We made China more innovative.Breakthroughs were made in developing manned spaceflight and the lunar exploration program, building a manned deep-sea submersible, launching the Beidou Navigation Satellite System, developing supercomputers and building high-speed railways.China's first aircraft carrier, the Liaoning, was commissioned.We successfully hosted the Games of the XXIX Olympiad and the XIII Paralympic Games in Beijing and the World Expo in Shanghai.We successfully mitigated the impact of the massive Wenchuan earthquake, the strong Yushu earthquake, the huge Zhugqu mudslide and other natural disasters and carried out post-disaster recovery and reconstruction.China's productive forces and overall national strength, its living standards and social security, and its international status and influence all improved significantly.We successfully completed the Eleventh Five-Year Plan and got off to a good start in implementing the Twelfth Five-Year Plan.We made significant socialist economic, political, cultural, social, and ecological progress, and wrote a new chapter in building socialism with Chinese characteristics.The following are the main work we accomplished over the past five years and its main features: 一是有效應(yīng)對國際金融危機(jī),促進(jìn)經(jīng)濟(jì)平穩(wěn)較快發(fā)展。過去五年,我們是在持續(xù)應(yīng)對國際金融危機(jī)嚴(yán)重沖擊中走過來的。這場危機(jī)來勢之猛、擴(kuò)散之快、影響之深,百年罕見。我們沉著應(yīng)對,及時(shí)果斷調(diào)整宏觀調(diào)控著力點(diǎn),出臺進(jìn)一步擴(kuò)大內(nèi)需、促進(jìn)經(jīng)濟(jì)平穩(wěn)較快增長的十項(xiàng)措施,全面實(shí)施一攬子計(jì)劃。兩年新增4萬億元投資,其中中央財(cái)政投資1.26萬億元,主要用于保障性安居工程、農(nóng)村民生工程、基礎(chǔ)設(shè)施、社會(huì)事業(yè)、生態(tài)環(huán)保、自主創(chuàng)新等方面建設(shè)和災(zāi)后恢復(fù)重建。五年來,新建各類保障性住房1800多萬套,棚戶區(qū)改造住房1200多萬套;完成大中型和重點(diǎn)小型水庫除險(xiǎn)加固1.8萬座,治理重點(diǎn)中小河流2.45萬公里,新增節(jié)水灌溉面積770萬公頃;新增鐵路里程1.97萬公里,其中高速鐵路8951公里,京滬、京廣、哈大等高鐵和一批城際鐵路相繼投入運(yùn)營;新增公路60.9萬公里,其中高速公路4.2萬公里,高速公路總里程達(dá)9.56萬公里;新建機(jī)場31個(gè);新增萬噸級港口泊位602個(gè);一批跨江跨海大橋、連島工程相繼建成;西氣東輸、西電東送、南水北調(diào)等重大工程順利推進(jìn)或建成;非化石能源快速發(fā)展,水電、風(fēng)電裝機(jī)位居世界第一;重建后的汶川、玉樹、舟曲等災(zāi)區(qū)發(fā)生了翻天覆地的變化。這些舉世矚目的成就,對我們有效應(yīng)對國際金融危機(jī)嚴(yán)重沖擊發(fā)揮了至關(guān)重要的作用,為經(jīng)濟(jì)社會(huì)長遠(yuǎn)發(fā)展打下了堅(jiān)實(shí)基礎(chǔ),已經(jīng)并將繼續(xù)造福億萬人民。
我們始終注重處理好保持經(jīng)濟(jì)平穩(wěn)較快發(fā)展、調(diào)整經(jīng)濟(jì)結(jié)構(gòu)和管理通脹預(yù)期的關(guān)系,增強(qiáng)宏觀政策的前瞻性、科學(xué)性、有效性,注意把握好政策的取向、力度和重點(diǎn)。在國際金融危機(jī)沖擊最嚴(yán)重時(shí),果斷實(shí)施積極的財(cái)政政策和適度寬松的貨幣政策,綜合運(yùn)用多種財(cái)政政策工具,增加政府支出,實(shí)行結(jié)構(gòu)性減稅;有效運(yùn)用存款準(zhǔn)備金率、利率等貨幣政策工具,保持貨幣信貸合理增長。根據(jù)宏觀經(jīng)濟(jì)走勢的變化,我們及時(shí)調(diào)整政策力度,適時(shí)退出刺激政策,實(shí)施積極的財(cái)政政策和穩(wěn)健的貨幣政策。在財(cái)政政策運(yùn)用上,堅(jiān)持統(tǒng)籌兼顧,注重綜合平衡。財(cái)政赤字占國內(nèi)生產(chǎn)總值的比重從2009年的2.8%降到去年的1.5%左右,赤字率和債務(wù)負(fù)擔(dān)率保持在安全水平。加強(qiáng)地方政府性債務(wù)全面審計(jì)和地方政府融資平臺管理,有效控制經(jīng)濟(jì)運(yùn)行中的風(fēng)險(xiǎn)隱患。在貨幣政策運(yùn)用上,始終注意把握穩(wěn)增長、控物價(jià)和防風(fēng)險(xiǎn)之間的平衡。金融體系運(yùn)行穩(wěn)健,銀行業(yè)風(fēng)險(xiǎn)抵御能力持續(xù)增強(qiáng),資本充足率從2007年底的8.4%提升到去年底的13.3%,不良貸款率由6.1%下降到0.95%。堅(jiān)持搞好房地產(chǎn)市場調(diào)控不動(dòng)搖,遏制了房價(jià)過快上漲勢頭。2012年,在世界各大經(jīng)濟(jì)體增長全面減速、各種風(fēng)險(xiǎn)不斷暴露的情況下,我們合理把握政策力度,保持財(cái)政預(yù)算支出規(guī)模不變,優(yōu)化支出結(jié)構(gòu),扭轉(zhuǎn)經(jīng)濟(jì)下滑趨勢,全面實(shí)現(xiàn)年初確定的主要目標(biāo),國內(nèi)生產(chǎn)總值增長7.8%,城鎮(zhèn)新增就業(yè)1266萬人,居民消費(fèi)價(jià)格漲幅回落到2.6%,為今年經(jīng)濟(jì)發(fā)展打下好的基礎(chǔ)。
這五年,我國宏觀經(jīng)濟(jì)總體上保持增速平穩(wěn)較快、物價(jià)相對穩(wěn)定、就業(yè)持續(xù)增加、國際收支趨于平衡的良好態(tài)勢,國內(nèi)生產(chǎn)總值年均增長9.3%,顯著高于同期全球和新興經(jīng)濟(jì)體的增速,通貨膨脹率遠(yuǎn)低于其他新興經(jīng)濟(jì)體。我國經(jīng)濟(jì)穩(wěn)定,充滿活力。
回首這五年,面對國際經(jīng)濟(jì)形勢復(fù)雜多變、持續(xù)低迷的嚴(yán)峻挑戰(zhàn),中央科學(xué)判斷、果斷決策,有效避免了我國現(xiàn)代化進(jìn)程因巨大的外部沖擊而出現(xiàn)大的波折,實(shí)踐證明這些決策部署是完全正確的。
In the past five years, we averted the grievous consequences of the global financial crisis, whose abruptness, rapid spread and profound impact were rarely seen in the past century.We responded to the crisis calmly, made timely and decisive adjustments to the focus of macro-control, adopted ten measures to increase domestic demand and promote steady and rapid economic growth, and implemented a comprehensive package plan.In a two-year period, an additional four trillion yuan of government investment was made, with 1.26 trillion yuan from the central government, mainly for building government-subsidized housing, improving rural people's wellbeing, building infrastructure, developing social programs, improving the environment, promoting innovation, and carrying out post-disaster recovery and reconstruction.Over the past five years: More than 18 million government-subsidized housing units of various types were built, and over 12 million housing units in run-down areas were upgraded.A total of 18,000 large and medium-sized and key small reservoirs were reinforced, 24,500 kilometers of key small and medium-length rivers were harnessed, and water-saving irrigated farmland was increased by 7.7 million hectares.A total of 19,700 kilometers of new rail lines were built, 8,951 kilometers of which are high-speed railways.The high-speed Beijing-Shanghai, Beijing-Guangzhou and Harbin-Dalian railways and a number of intercity railways were opened to traffic.A total of 609,000 kilometers of new roads were built, 42,000 kilometers of which are expressways, increasing the total length of expressways in service to 95,600 kilometers.Thirty-one airports and 602 shipping berths for 10,000-ton ships were built.A number of bridges over rivers and bays and linking islands with other islands and the mainland were completed.Smooth progress was made in major projects such as those for transporting natural gas and electricity from the west to the east and diverting water from the south to the north, and some of the projects have been completed.Non-fossil energy production developed rapidly, and China now ranks first in the world in the installed capacity of both hydropower and wind power.Reconstruction of the Wenchuan, Yushu and Zhugqu disaster areas transformed them completely.These impressive achievements played a vital role in our effective response to the severe impact of the global financial crisis, and laid a solid foundation for sustaining China's economic and social development.They have benefited and will continue to benefit hundreds of millions of people.We always strove to maintain a balance between ensuring steady and rapid economic development, adjusting the economic structure, and managing inflation expectations.We made government macro policies more forward-looking, scientific and effective and implemented them with proper orientation, force and focus.When the impact of the global financial crisis was at its worst, we resolutely implemented a proactive fiscal policy and a moderately easy monetary policy, employed a full range of financial policy tools, increased government spending and made structural tax reductions.We effectively employed monetary policy instruments such as adjusting required reserve ratios and interest rates to maintain proper growth in the money and credit supply.In response to changing macroeconomic trends, we promptly adjusted the intensity of policy implementation, reduced the force of stimulus policies at an appropriate time, and implemented a proactive fiscal policy and a prudent monetary policy.We took a holistic and balanced approach in employing fiscal policy.As a result, the government deficit dropped from 2.8% of GDP in 2009 to about 1.5% last year, and both deficit-to-GDP and debt-to-GDP ratios remained at a safe level.We strengthened comprehensive auditing of local governments' debt and management of their financing platforms, thus effectively controlling latent economic risks.In employing monetary policy, we maintained a balance between ensuring steady growth, maintaining price stability and warding off risks.The financial system functioned soundly.The banking sector became better able to avert risks.Its capital adequacy rate increased from 8.4% at the end of 2007 to 13.3% by the end of last year, and its non-performing loans dropped from 6.1% to 0.95%.We kept a firm grip on the real estate market and kept housing prices from rising too quickly.In 2012, when other major economies in the world were experiencing a slowdown in growth and constantly encountered new risks, we maintained a proper intensity in policy implementation, kept budgetary spending unchanged, improved the spending mix, and reversed the decline in economic growth.As a result, we attained all the main targets set at the beginning of the year: GDP grew by 7.8%, 12.66 million urban jobs were created, and the rise in the CPI fell to 2.6%.All this laid a good foundation for China's economic development this year.Over the past five years: China's economy as a whole maintained steady and rapid growth.Prices remained fairly stable.Employment steadily increased.The balance of payments moved toward equilibrium.GDP grew at an average annual rate of 9.3%, considerably higher than the average global rate and the average rate of other emerging economies for the same period.China's inflation rate was also much lower than that of other emerging economies.The Chinese economy is stable and full of vitality.In the last five years, faced with severe challenges posed by a complex and volatile international economic environment and a sluggish global economy, the central leadership, on the basis of a scientific judgment of the situation, made resolute decisions that steered China's modernization drive clear of major pitfalls created by huge external shocks.Experience fully proves these decisions and implementing steps were entirely correct.二是加快經(jīng)濟(jì)結(jié)構(gòu)調(diào)整,提高經(jīng)濟(jì)發(fā)展的質(zhì)量和效益。堅(jiān)持實(shí)施擴(kuò)大內(nèi)需戰(zhàn)略,內(nèi)需對經(jīng)濟(jì)增長的貢獻(xiàn)率明顯提高,經(jīng)常項(xiàng)目順差占國內(nèi)生產(chǎn)總值的比重從10.1%下降到2.6%。居民消費(fèi)結(jié)構(gòu)加快升級。2012年底,城鎮(zhèn)和農(nóng)村人均住房面積32.9平方米、37.1平方米,分別比2007年增加2.8平方米和5.5平方米;城鎮(zhèn)居民每百戶擁有家用汽車21.5輛,比2007年增加15.5輛;旅游、文化消費(fèi)大幅增加。堅(jiān)持走中國特色新型工業(yè)化道路,大力推進(jìn)產(chǎn)業(yè)轉(zhuǎn)型升級。我國制造業(yè)規(guī)模躍居全球首位,高技術(shù)制造業(yè)增加值年均增長13.4%,成為國民經(jīng)濟(jì)重要先導(dǎo)性、支柱性產(chǎn)業(yè);清潔能源、節(jié)能環(huán)保、新一代信息技術(shù)、生物醫(yī)藥、高端裝備制造等一批戰(zhàn)略性新興產(chǎn)業(yè)快速發(fā)展。產(chǎn)品質(zhì)量整體水平不斷提高。服務(wù)業(yè)增加值占國內(nèi)生產(chǎn)總值比重提高2.7個(gè)百分點(diǎn),成為吸納就業(yè)最多的產(chǎn)業(yè)。扎實(shí)推進(jìn)節(jié)能減排和生態(tài)環(huán)境保護(hù)。五年累計(jì),共淘汰落后煉鐵產(chǎn)能1.17億噸、煉鋼產(chǎn)能7800萬噸、水泥產(chǎn)能7.75億噸;新增城市污水日處理能力4600萬噸;單位國內(nèi)生產(chǎn)總值能耗下降17.2%,化學(xué)需氧量、二氧化硫排放總量分別下降15.7%和17.5%。修訂環(huán)境空氣質(zhì)量標(biāo)準(zhǔn),增加細(xì)顆粒物PM2.5等監(jiān)測指標(biāo)。推進(jìn)天然林保護(hù)、退耕還林、防沙治沙等重點(diǎn)生態(tài)工程建設(shè),五年累計(jì)完成造林2953萬公頃,治理沙漠化、石漠化土地1196萬公頃,綜合治理水土流失面積24.6萬平方公里,整治國土面積18萬平方公里。深入實(shí)施區(qū)域發(fā)展總體戰(zhàn)略,頒布實(shí)施全國主體功能區(qū)規(guī)劃,制定西部大開發(fā)新十年指導(dǎo)意見和一系列區(qū)域發(fā)展規(guī)劃,加快推進(jìn)西藏、新疆等地區(qū)跨越式發(fā)展,制定實(shí)施新十年農(nóng)村扶貧開發(fā)綱要,將扶貧標(biāo)準(zhǔn)提高到2300元(2010年不變價(jià)),加強(qiáng)集中連片特殊困難地區(qū)扶貧攻堅(jiān)。中西部和東北地區(qū)主要發(fā)展指標(biāo)增速高于全國平均水平,東部地區(qū)產(chǎn)業(yè)轉(zhuǎn)型升級步伐加快,各具特色、良性互動(dòng)的區(qū)域發(fā)展格局正在形成。積極穩(wěn)妥推進(jìn)城鎮(zhèn)化,五年轉(zhuǎn)移農(nóng)村人口8463萬人,城鎮(zhèn)化率由45.9%提高到52.6%,城鄉(xiāng)結(jié)構(gòu)發(fā)生了歷史性變化。城鄉(xiāng)、區(qū)域發(fā)展的協(xié)調(diào)性明顯增強(qiáng)。
2.Accelerating adjustment of the economic structure and improving the quality and performance of economic development We adhered to the strategy of expanding domestic demand.As a result, the contribution of domestic demand to economic growth increased significantly, and the share of current account surplus in the GDP dropped from 10.1% to 2.6%.The upgrading in the mix of private consumption accelerated.--At the end of 2012, the per capita living area of urban and rural residents was 32.9 square meters and 37.1 square meters respectively, an increase of 2.8 and 5.5 over 2007.--Car ownership stood at 21.5 cars per 100 urban households, an increase of 15.5 over 2007.--Travel-and entertainment-related spending has risen substantially.We adhered to the new path of industrialization with distinctive Chinese features and promoted transformation and upgrading of industrial sectors.--China's manufacturing industry became the largest in the world.With added-value growing at an average annual rate of 13.4% during the past five years, high-tech manufacturing has become a leading pillar of the economy.--Strategic emerging industries grew rapidly, including clean energy, energy conservation, environmental protection, next-generation information and communication technology, biomedicines, and high-end equipment manufacturing.--The overall quality of manufactured goods steadily improved.--The share of value-added of the service sector in the GDP increased by 2.7 percentage points, and it now creates more jobs than any other sector.We made steady progress in conserving energy, reducing emissions, and protecting the environment.Over the past five years, the following backward production facilities were closed:--Iron works with a total output capacity of 117 million tons.--Steel mills with a capacity of 78 million tons.--Cement plants with a capacity of 775 million tons.Moreover, in the past five years:--Daily urban sewage treatment capacity increased by 46 million tons.--Energy consumption per unit of GDP fell by 17.2%.--Total chemical oxygen demand fell by 15.7%.--Total sulfur dioxide emissions fell by 17.5%.--Environmental air quality standards were revised.--The air quality index for monitoring fine particulate matter(PM2.5)was added.Progress was made in major ecological projects to protect virgin forests, afforest marginal farmland, and prevent and control desertification.Over the past five years:--An additional 29.53 million hectares of land were planted with trees.--Desertification was halted on 11.96 million hectares of land.--Soil erosion on 246,000 square kilometers of land was brought under control.--A total of 180,000 square kilometers of land were improved.We implemented the master strategy for regional development, promulgated and implemented the national plan for developing functional zones, formulated new ten-year guidelines for the large-scale development of the western region and a number of regional development plans, and accelerated leapfrog development of Tibet and Xinjiang.We formulated and implemented a new ten-year program for rural poverty alleviation and development, raised the poverty line to 2,300 yuan at 2010 prices, and intensified efforts to alleviate poverty in contiguous areas with acute difficulties.Major economic indicators rose faster in the central and western regions and northeast China than the national average.Transformation and upgrading of the industrial sector in the eastern region accelerated, and a pattern of regional development is taking shape in which each region both has its distinctive strengths and draws on the strengths of other regions.We advanced urbanization actively yet prudently.Over the past five years:--A total of 84.63 million rural residents migrated to urban areas.--The urbanization level rose from 45.9% to 52.6%, marking a historic turning point in China's urban-rural population structure.Development between urban and rural areas and between regions became more balanced.三是毫不放松地抓好“三農(nóng)”工作,鞏固和加強(qiáng)農(nóng)業(yè)基礎(chǔ)地位。我們堅(jiān)持在工業(yè)化、信息化、城鎮(zhèn)化深入發(fā)展中同步推進(jìn)農(nóng)業(yè)現(xiàn)代化,集中力量辦成了一些關(guān)系農(nóng)業(yè)農(nóng)村長遠(yuǎn)發(fā)展、關(guān)系農(nóng)民切身利益的大事。加大財(cái)政投入,中央財(cái)政“三農(nóng)”累計(jì)支出4.47萬億元,年均增長23.5%。建立健全種糧農(nóng)民補(bǔ)貼制度和主產(chǎn)區(qū)利益補(bǔ)償機(jī)制,補(bǔ)貼標(biāo)準(zhǔn)逐年提高,覆蓋范圍不斷擴(kuò)大,補(bǔ)貼資金從2007年的639億元增加到2012年的1923億元。加強(qiáng)農(nóng)村金融服務(wù),涉農(nóng)貸款余額從2007年末的6.12萬億元增加到2012年末的17.63萬億元。實(shí)行糧食最低收購價(jià)政策,小麥、稻谷最低收購價(jià)累計(jì)提高41.7%到86.7%。加強(qiáng)耕地保護(hù),維護(hù)農(nóng)民權(quán)益,為完善農(nóng)村集體土地征收補(bǔ)償制度做了大量準(zhǔn)備工作。加快推進(jìn)農(nóng)業(yè)科技進(jìn)步和現(xiàn)代農(nóng)業(yè)建設(shè),加大對良種繁育、動(dòng)植物疫病防控、基層農(nóng)技推廣的支持力度。大力興修水利,開展農(nóng)村土地整治,建設(shè)高標(biāo)準(zhǔn)農(nóng)田,耕地面積保持在18.2億畝以上。糧食綜合生產(chǎn)能力躍上新臺階,糧食總產(chǎn)量連續(xù)6年穩(wěn)定在萬億斤以上并逐年增加。加強(qiáng)農(nóng)村水電路氣等基礎(chǔ)設(shè)施建設(shè),新建改建農(nóng)村公路146.5萬公里,改造農(nóng)村危房1033萬戶,解決了3億多農(nóng)村人口的飲水安全和無電區(qū)445萬人的用電問題,農(nóng)村生產(chǎn)生活條件不斷改善。積極引導(dǎo)農(nóng)村富余勞動(dòng)力轉(zhuǎn)向非農(nóng)產(chǎn)業(yè),農(nóng)民人均純收入持續(xù)較快增長,2010年以來城鄉(xiāng)居民相對收入差距逐步縮小。深化農(nóng)村綜合改革。集體林權(quán)制度主體改革基本完成,全面推進(jìn)農(nóng)村集體土地確權(quán)頒證工作,開展農(nóng)村土地承包經(jīng)營權(quán)登記試點(diǎn)。農(nóng)業(yè)農(nóng)村發(fā)展的好形勢,為應(yīng)對國際金融危機(jī)和各種自然災(zāi)害嚴(yán)重沖擊、穩(wěn)定經(jīng)濟(jì)社會(huì)發(fā)展大局提供了重要支撐。
3.Unremittingly doing our work related to agriculture, rural areas, and farmers well, and consolidating and strengthening the position of agriculture as the foundation of the economy We carried out agricultural modernization while deepening industrialization, application of information and communication technologies(ICT), and urbanization, and we pooled resources to accomplish a number of major tasks that are important to the long-term development of agriculture and rural areas and to the vital interests of farmers.--We increased central government spending on agriculture, rural areas and farmers, which totaled 4.47 trillion yuan for the past five years and rose by an average annual rate of 23.5%.--We established a sound system for subsidizing grain farmers and a sound mechanism for subsidizing major grain-producing areas, broadened the coverage of the subsidies, and raised them every year, from 63.9 billion yuan in 2007 to 192.3 billion yuan in 2012.--We provided more rural financial services, and the outstanding balance of bank loans to agriculture, rural areas and farmers increased from 6.12 trillion yuan at the end of 2007 to 17.63 trillion yuan at the end of 2012.--We carried out the policy of minimum grain purchase prices and raised the floor prices for wheat and rice between 41.7% and 86.7%.--We intensified protection of farmland and farmers' rights and interests, and made a lot of preparations to improve the system of compensating for expropriation of rural collective land.--We made greater progress in agricultural science and technology and the development of modern agriculture, and we increased support for cultivating superior varieties and breeds, preventing and controlling animal and plant epidemics, and spreading agricultural technology in villages.--We built more water conservancy projects, improved rural land, developed high-grade farmland, and kept the country's total area of farmland over 121.3 million hectares.--Thanks to these efforts, China's overall grain production capacity reached a new level, and its grain output in each of the past six years increased and exceeded 500 million tons.--We strengthened rural infrastructure such as roads and water, power and methane supply capacity.We built or upgraded 1.465 million kilometers of rural roads, renovated run-down houses for 10.33 million rural households, provided safe drinking water for an additional 300 million plus rural residents, and delivered electricity to 4.45 million people in areas without power supply.This led to steady improvement in rural productivity and quality of life.--We encouraged surplus rural workers to find nonagricultural employment.The per capita net income of rural residents grew rapidly, and the relative income gap between urban and rural residents has progressively narrowed since 2010.--We deepened overall rural reform.--We basically completed the main tasks for reforming the collective forest tenure system, made comprehensive progress in determining, registering and certifying collective land ownership, and carried out trials for registering contracted rural land-use rights.Sound agricultural and rural development provided important support for China to counter the severe impact of the global financial crisis and natural disasters and maintain overall stability in economic and social development.四是堅(jiān)持實(shí)施科教興國戰(zhàn)略,增強(qiáng)經(jīng)濟(jì)社會(huì)發(fā)展的核心支撐能力。我們加快實(shí)施國家中長期科學(xué)和技術(shù)發(fā)展規(guī)劃綱要,制定實(shí)施國家中長期教育改革和發(fā)展規(guī)劃綱要、國家中長期人才發(fā)展規(guī)劃綱要和國家知識產(chǎn)權(quán)戰(zhàn)略,推動(dòng)科技、教育、文化事業(yè)全面發(fā)展,為國家長遠(yuǎn)發(fā)展奠定了堅(jiān)實(shí)基礎(chǔ)。
優(yōu)先發(fā)展教育事業(yè)。國家財(cái)政性教育經(jīng)費(fèi)支出五年累計(jì)7.79萬億元,年均增長21.58%,2012年占國內(nèi)生產(chǎn)總值比例達(dá)到4%。教育資源重點(diǎn)向農(nóng)村、邊遠(yuǎn)、民族、貧困地區(qū)傾斜,教育公平取得明顯進(jìn)步。全面實(shí)現(xiàn)城鄉(xiāng)九年免費(fèi)義務(wù)教育,惠及1.6億學(xué)生。實(shí)施學(xué)前教育三年行動(dòng)計(jì)劃,“入園難”問題有所緩解。國家助學(xué)制度不斷完善,建立了家庭經(jīng)濟(jì)困難學(xué)生資助體系,實(shí)現(xiàn)從學(xué)前教育到研究生教育各個(gè)階段全覆蓋,每年資助金額近1000億元,資助學(xué)生近8000萬人次。實(shí)施中等職業(yè)教育免學(xué)費(fèi)政策,覆蓋范圍包括所有農(nóng)村學(xué)生、城市涉農(nóng)專業(yè)學(xué)生和家庭經(jīng)濟(jì)困難學(xué)生。初步解決進(jìn)城務(wù)工人員隨遷子女在城市接受義務(wù)教育問題,現(xiàn)有1260萬農(nóng)村戶籍孩子在城市接受義務(wù)教育。實(shí)施惠及3000多萬農(nóng)村義務(wù)教育階段學(xué)生營養(yǎng)改善計(jì)劃。完成中小學(xué)校舍安全工程。加快職業(yè)教育基礎(chǔ)能力和特殊教育基礎(chǔ)設(shè)施建設(shè)。義務(wù)教育學(xué)校實(shí)施績效工資,在教育部直屬師范大學(xué)實(shí)行師范生免費(fèi)教育,加強(qiáng)了農(nóng)村教師隊(duì)伍建設(shè)。全面提高教育質(zhì)量和水平,高等教育毛入學(xué)率提高到30%。國民受教育程度大幅提升,15歲以上人口平均受教育年限達(dá)到9年以上。大力推動(dòng)自主創(chuàng)新。中央財(cái)政用于科技的投入五年累計(jì)8729億元,年均增長超過18%。全社會(huì)研究與試驗(yàn)發(fā)展經(jīng)費(fèi)支出占國內(nèi)生產(chǎn)總值的比重由2007年的1.4%提高到2012年的1.97%,企業(yè)研發(fā)活動(dòng)支出占比超過74%。出臺深化科技體制改革加快國家創(chuàng)新體系建設(shè)的意見。深入實(shí)施國家技術(shù)創(chuàng)新工程和知識創(chuàng)新工程,扎實(shí)推進(jìn)國家科技重大專項(xiàng),新建一批國家工程中心、重點(diǎn)實(shí)驗(yàn)室和企業(yè)技術(shù)中心。加強(qiáng)基礎(chǔ)研究和前沿探索,突破一批關(guān)鍵核心技術(shù),填補(bǔ)了多項(xiàng)重大產(chǎn)品和裝備的空白。
深入實(shí)施人才強(qiáng)國戰(zhàn)略。以高層次、高技能人才為重點(diǎn),加強(qiáng)各類人才隊(duì)伍建設(shè),專業(yè)技術(shù)人才、高技能人才分別增加860萬人和880萬人,留學(xué)回國人員達(dá)到54萬人。大力加強(qiáng)文化建設(shè)。覆蓋城鄉(xiāng)的公共文化設(shè)施網(wǎng)絡(luò)體系初步建成,博物館、圖書館、文化館(站)實(shí)現(xiàn)免費(fèi)開放。國有經(jīng)營性文化單位轉(zhuǎn)企改制任務(wù)基本完成,公益性文化事業(yè)單位內(nèi)部機(jī)制改革不斷深化。哲學(xué)社會(huì)科學(xué)、新聞出版、廣播影視、文學(xué)藝術(shù)等更加繁榮,文化產(chǎn)業(yè)快速發(fā)展。文物保護(hù)、非物質(zhì)文化遺產(chǎn)保護(hù)和傳承取得重要進(jìn)展。對外文化交流更加活躍。全民健身和競技體育取得新成績。
4.Steadfastly implementing the strategy for making China strong through the development of science and education, and boosting the country's core ability to sustain economic and social development We accelerated implementation of the National Plan for Long-and Medium-Term Scientific and Technological Development;formulated and implemented the National Plan for Long-and Medium-Term Education Reform and Development, the National Plan for Long-and Medium-Term Development of Competent Personnel and the national strategy on intellectual property rights.This gave impetus to all-around progress in science and technology, education, and culture and laid a solid foundation for ensuring China's long-term development.We gave high priority to developing education.Government spending on education totaled 7.79 trillion yuan over the past five years, increasing at an average annual rate of 21.58% to reach 4% of GDP in 2012.We allocated educational resources, giving priority to rural, remote, poor and ethnic minority areas and made notable progress in improving fairness in education.We made free nine-year compulsory education universal across the country, benefiting 160 million students.A three-year action plan for preschool education was carried out, and the shortage of preschools was eased.We improved the system of state financial aid to students, and established a system for giving students from poor families financial aid from preschool through graduate school.We spent approximately 100 billion yuan annually for this purpose and assisted nearly 80 million students.We implemented the policy of tuition-free secondary vocational education for all rural students and all urban students who study agriculture-related majors or are from poor families.The problem of providing compulsory education to children of rural migrants working in cities was basically solved, and 12.6 million children with rural residence status are now receiving compulsory education in cities.We implemented the plan for improving nutrition of rural students receiving compulsory education to the benefit of over 30 million students.We completed the project to improve the safety of primary and secondary school buildings.We sped up development of infrastructure for vocational and special education.The pay of teachers in compulsory education is now linked to their performance.Students majoring in education at teachers universities directly under the Ministry of Education were exempted from paying tuition, and the ranks of rural teachers were strengthened.The quality and level of education in China was comprehensively raised, and the gross college enrollment rate rose to 30%.The education level of the people was raised significantly, and the average length of schooling of people over the age of 15 now exceeds nine years.We vigorously promoted innovation.The central government spent 872.9 billion yuan to develop science and technology in the past five years, with an average annual increase of over 18%.China's R&D spending accounted for 1.97% of GDP in 2012, up from 1.4% in 2007, and over 74% of this spending was made by companies.The Guidelines on Deepening Reform of the Management System for Science and Technology and Accelerating Development of a National Innovation System were adopted.We carried out a national technology innovation project and a knowledge innovation project, made solid progress in implementing major national R&D projects, and set up a number of national engineering centers, key laboratories and enterprise technology centers.We boosted basic research and research in frontier areas, made breakthroughs in a number of core and key technologies, and filled in gaps in many important products and equipment.We implemented the strategy for making China strong through training competent personnel.We trained more personnel of all types, with the focus on high-level and highly skilled personnel.As a result, the number of personnel with special expertise and highly skilled personnel increased by 8.6 million and 8.8 million respectively.A total of 540,000 overseas students returned.We put greater effort into developing the cultural sector.A network of public cultural facilities covering both urban and rural areas is taking shape, and all museums, libraries and cultural centers in China are open to the public free of charge.We basically transformed state-owned for-profit cultural institutions into business enterprises, and deepened reform of internal operating mechanisms of nonprofit cultural institutions.Philosophy and the social sciences, the press and publishing, radio, television and film, and literature and art are flourishing, and cultural industries developed rapidly.We made major progress in protecting cultural relics and preserving and passing on intangible cultural heritage.Cultural exchanges with other countries increased.New progress was made in nationwide fitness activities and competitive sports.五是堅(jiān)持把人民利益放在第一位,著力保障和改善民生。我們把就業(yè)作為保障和改善民生的頭等大事,實(shí)施積極的就業(yè)政策。加強(qiáng)重點(diǎn)人群就業(yè)工作,提高職業(yè)培訓(xùn)和就業(yè)服務(wù)水平,五年累計(jì)投入就業(yè)專項(xiàng)資金1973億元,實(shí)現(xiàn)高校畢業(yè)生就業(yè)2800萬人,城鎮(zhèn)就業(yè)困難人員就業(yè)830萬人,保持了就業(yè)形勢總體穩(wěn)定。全面推進(jìn)社會(huì)保障體系建設(shè),建立新型農(nóng)村社會(huì)養(yǎng)老保險(xiǎn)和城鎮(zhèn)居民社會(huì)養(yǎng)老保險(xiǎn)制度,城鄉(xiāng)居民基本養(yǎng)老保險(xiǎn)實(shí)現(xiàn)了制度全覆蓋,各項(xiàng)養(yǎng)老保險(xiǎn)參保達(dá)到7.9億人。企業(yè)退休人員基本養(yǎng)老金從2004年人均每月700元提高到現(xiàn)在的1721元。妥善解決關(guān)閉破產(chǎn)企業(yè)退休人員、困難企業(yè)職工、國有企業(yè)老工傷人員、未參保集體企業(yè)退休人員社會(huì)保險(xiǎn)等問題。深化醫(yī)藥衛(wèi)生體制改革,建立新型農(nóng)村合作醫(yī)療制度和城鎮(zhèn)居民基本醫(yī)療保險(xiǎn)制度,全民基本醫(yī)保體系初步形成,各項(xiàng)醫(yī)療保險(xiǎn)參保超過13億人,加強(qiáng)城鄉(xiāng)基層醫(yī)療衛(wèi)生服務(wù)體系建設(shè),建立基本藥物制度并在基層醫(yī)療機(jī)構(gòu)實(shí)施,公立醫(yī)院改革試點(diǎn)穩(wěn)步推進(jìn)。國民健康水平進(jìn)一步提高,人均預(yù)期壽命達(dá)到75歲。健全城鄉(xiāng)居民低保、醫(yī)療、教育、法律等救助制度,改革完善孤兒保障、流浪兒童救助保護(hù)、農(nóng)村五保供養(yǎng)制度。頒布實(shí)施新的中國婦女、兒童發(fā)展綱要,依法保障婦女兒童合法權(quán)益。建立健全城鎮(zhèn)保障性住房制度,覆蓋面逐步擴(kuò)大,2012年底已達(dá)到12.5%。社會(huì)保障制度建設(shè)取得歷史性的巨大成就。不斷加強(qiáng)和創(chuàng)新社會(huì)管理,建立健全應(yīng)急管理體系,發(fā)揮城鄉(xiāng)社區(qū)自治和服務(wù)功能,社會(huì)保持和諧穩(wěn)定。
5.Putting the people's interests first and striving to ensure and improve their wellbeing We made expanding employment the top priority in ensuring and improving people's wellbeing and pursued a proactive employment policy.Over the past five years, we allocated 197.3 billion yuan of employment funds to help targeted groups obtain employment and to improve vocational training and employment services.As a result, 28 million university graduates and 8.3 million urban residents having difficulty finding jobs found employment.All this kept the overall employment situation stable.We made comprehensive progress in developing the social security system: A new old-age insurance system for rural residents and an old-age insurance system for non-working urban residents were established, and the basic old-age insurance system now covers both urban and rural residents.A total of 790 million people are now covered by different old-age insurance schemes.Basic pensions for enterprise retirees rose from an average of 700 yuan per month in 2004 to 1,721 yuan at present.We extended social security coverage to retirees of closed or bankrupt enterprises, employees of enterprises with operating difficulties, employees of state-owned enterprises who suffered work-related injuries in the past, and uninsured retirees of collectively owned enterprises.We deepened reform of the medical and health care systems, established a new type of rural cooperative medical care system and a basic medical insurance scheme for non-working urban residents.A basic medical insurance system that covers the whole population is taking shape, and over 1.3 billion people are now covered by different medical insurance schemes.We improved community-level medical and health care services, and established a system for using basic drugs and implemented it in community-level medical institutions.Steady progress was made in the trial reform of public hospitals.People's health further improved, and the average life expectancy reached 75 years.The systems for aiding needy rural and urban residents with subsistence allowances, medical care, education and legal assistance were improved.We reformed and improved systems for providing social security to orphans, helping and protecting homeless children, and giving childless and infirm rural residents assistance in the form of food, clothing, medical care, housing, and burial expenses.We promulgated and implemented new programs for the development of Chinese women and children, and protected their legitimate rights and interests in accordance with the law.We established a sound government-subsidized urban housing system and extended it to cover 12.5% of the country's urban households by the end of 2012.Historic achievements were made in developing the social security system.We strengthened and made innovations in social management, put in place a sound emergency response system, encouraged urban and rural communities to fully play their self-governance and service roles, and maintained social harmony and stability.六是深化重要領(lǐng)域改革,增強(qiáng)經(jīng)濟(jì)社會(huì)發(fā)展的內(nèi)在活力。我們不失時(shí)機(jī)地推進(jìn)改革,在一些重要領(lǐng)域取得重大進(jìn)展。大力推進(jìn)財(cái)稅體制改革,完善轉(zhuǎn)移支付制度,全面建立縣級基本財(cái)力保障機(jī)制,基層政府提供基本公共服務(wù)的能力有所提高;由公共財(cái)政預(yù)算、政府性基金預(yù)算、國有資本經(jīng)營預(yù)算、社會(huì)保險(xiǎn)基金預(yù)算組成的預(yù)算體系框架基本形成,預(yù)算外資金全部納入預(yù)算管理;統(tǒng)一內(nèi)外資企業(yè)稅制,實(shí)現(xiàn)增值稅轉(zhuǎn)型,實(shí)施成品油價(jià)格和稅費(fèi)改革,開展?fàn)I業(yè)稅改征增值稅試點(diǎn),改革資源稅制度,財(cái)稅體制對加快轉(zhuǎn)變經(jīng)濟(jì)發(fā)展方式的促進(jìn)作用增強(qiáng)。全面深化金融體制改革,國有大型商業(yè)銀行股份制改革順利完成,政策性金融機(jī)構(gòu)改革有序推進(jìn),農(nóng)村信用社改革成效明顯,銀行業(yè)新監(jiān)管標(biāo)準(zhǔn)實(shí)施,創(chuàng)業(yè)板、股指期貨和融資融券業(yè)務(wù)相繼推出,保險(xiǎn)業(yè)改革開放深入推進(jìn),人民幣匯率形成機(jī)制不斷完善,利率市場化和資本項(xiàng)目可兌換改革穩(wěn)步推進(jìn),建立宏觀審慎政策框架,擴(kuò)大人民幣在跨境貿(mào)易和投資中的使用。我國銀行、證券、保險(xiǎn)業(yè)的抗風(fēng)險(xiǎn)能力和國際競爭力顯著提升,為成功應(yīng)對國際金融危機(jī)沖擊奠定了堅(jiān)實(shí)基礎(chǔ)。國有企業(yè)改革不斷深化,素質(zhì)提高,競爭力明顯增強(qiáng)。制定鼓勵(lì)和引導(dǎo)民間投資健康發(fā)展的指導(dǎo)意見和實(shí)施細(xì)則,非公有制經(jīng)濟(jì)發(fā)展環(huán)境不斷改善。建立生態(tài)補(bǔ)償制度,開展排污權(quán)和碳排放權(quán)交易試點(diǎn)。事業(yè)單位分類改革積極推進(jìn)。
6.Deepening reform in key areas and enhancing the vitality of economic and social development We lost no opportunity to carry out reform and achieved great progress in a number of key areas.We vigorously reformed the fiscal and taxation systems, improved the system of transfer payments and established a mechanism for ensuring basic funding for county-level governments across the country.County-and township-level governments became more capable of providing basic public services.We put in place the basic framework of a system of budgets for public finances, government-managed funds, state capital operations and social security funds, and all extrabudgetary funds were placed under budgetary management.We unified the corporate tax systems for domestic and overseas-funded enterprises, implemented VAT reform, reformed pricing of refined oil products and related taxes and fees, carried out pilot projects to replace business tax with VAT, and reformed the resource tax system.This strengthened the role of the fiscal and taxation systems in accelerating the change of the growth model.We comprehensively deepened reform of the financial system.Specifically, we smoothly completed the transformation of large state-owned commercial banks into joint-stock companies and carried out reform of policy-based financial institutions in an orderly way.We made notable achievements in reforming rural credit cooperatives, implemented new oversight and supervision standards in the banking industry, launched the ChiNext stock market, and introduced stock index futures and securities margin trading.We deepened reform of the insurance industry and opened it wider.We improved the mechanism for setting the RMB exchange rate, made steady progress in making interest rates more market-based and promoting the RMB's convertibility under capital accounts, established a macroprudential policy framework, and expanded the use of the RMB in cross-border trade and investment.China's banking, securities and insurance industries became significantly more resilient to risks and internationally competitive, and they underpinned our successful response to the global financial crisis.Reform of state-owned enterprises deepened, their performance improved and their competitiveness was significantly enhanced.We formulated the Guidelines on Encouraging and Guiding the Sound Development of Nongovernmental Investment and rules for their implementation, and the environment for the development of the non-public sector of the economy improved.We adopted a system for compensating for ecological damage and carried out trials for trading pollution discharge and carbon emission rights.We carried out function-based reform of public institutions.七是堅(jiān)定不移擴(kuò)大對外開放,全面提升開放型經(jīng)濟(jì)水平。我們積極應(yīng)對外部環(huán)境的急劇變化,及時(shí)出臺穩(wěn)定外需的政策措施,實(shí)施市場多元化戰(zhàn)略,進(jìn)出口總額年均增長12.2%,從世界第三位提升到第二位,其中出口額躍居世界第一位,占國際市場份額比2007年提高2個(gè)多百分點(diǎn),進(jìn)出口結(jié)構(gòu)優(yōu)化,貿(mào)易大國地位進(jìn)一步鞏固。五年累計(jì)實(shí)際利用外資5528億美元,利用外資的結(jié)構(gòu)和布局明顯優(yōu)化,質(zhì)量和水平顯著提升。加快實(shí)施“走出去”戰(zhàn)略,鼓勵(lì)各類企業(yè)開展對外投資和跨國經(jīng)營,非金融類對外直接投資從2007年的248億美元上升到2012年的772億美元,年均增長25.5%,躋身對外投資大國行列。對外開放有力促進(jìn)了我國經(jīng)濟(jì)發(fā)展和結(jié)構(gòu)優(yōu)化,吸收了先進(jìn)技術(shù)和管理經(jīng)驗(yàn),增加了就業(yè)和職工收入,也為推動(dòng)世界經(jīng)濟(jì)復(fù)蘇作出了重要貢獻(xiàn)。
7.Unswervingly opening wider to the outside world and comprehensively improving the performance of the open economy We actively responded to drastic changes in the external environment, promptly introduced policies and measures to stabilize external demand, and implemented the strategy of diversifying markets.During the past five years, China's import and export volume grew by an annual average of 12.2% and rose from third to second place in the world.China has become the largest exporter in the world, and its international market share increased by over two percentage points over 2007.China's import and export mix improved, and its status as a trading power was further strengthened.Over the past five years, we utilized US$ 552.8 billion of foreign investment, considerably improved the structure and distribution of this investment, and made much better use of it.We quickened the implementation of the “go global” strategy and encouraged enterprises of various types to invest and operate overseas.Non-financial outward direct investment increased from $24.8 billion in 2007 to $77.2 billion in 2012, growing at an average annual rate of 25.5%.This turned China into a major overseas investor country.Opening up vigorously stimulated China's economic development and structural improvement, brought in advanced foreign technologies and managerial expertise, and increased employment and workers' income, and also made an important contribution to global economic recovery.八是切實(shí)加強(qiáng)政府自身建設(shè),進(jìn)一步深化行政體制改革。推進(jìn)政府機(jī)構(gòu)改革,初步建立職能統(tǒng)一的大部門體制框架。我們始終把實(shí)行科學(xué)民主決策、堅(jiān)持依法行政、推進(jìn)政務(wù)公開、健全監(jiān)督制度、加強(qiáng)廉政建設(shè)作為政府工作的基本準(zhǔn)則。在規(guī)范行政權(quán)力運(yùn)行,建設(shè)服務(wù)政府、責(zé)任政府、法治政府和廉潔政府方面,采取了一系列新舉措,邁出了新步伐。堅(jiān)持科學(xué)決策、民主決策、依法決策,健全公眾參與、專家論證、風(fēng)險(xiǎn)評估、合法性審查和集體討論決定等政府決策程序。深化行政審批制度改革,五年中分兩輪取消和調(diào)整行政審批事項(xiàng)498項(xiàng),國務(wù)院各部門取消和調(diào)整的審批項(xiàng)目總數(shù)達(dá)到2497項(xiàng),占原有審批項(xiàng)目的69.3%。大力推動(dòng)政務(wù)公開,重點(diǎn)推進(jìn)財(cái)政預(yù)算決算公開和公務(wù)接待、公務(wù)車購置使用、因公出國出境經(jīng)費(fèi)公開,讓人民群眾更加全面地了解政府工作,更加有效地監(jiān)督政府行為。審計(jì)監(jiān)督的力度越來越大,成效越來越明顯。全面加強(qiáng)反腐倡廉建設(shè),加強(qiáng)領(lǐng)導(dǎo)干部廉潔自律的監(jiān)督管理。探索建立政府績效管理制度,建立并切實(shí)執(zhí)行以行政首長為重點(diǎn)的行政問責(zé)制度,努力提高行政效能。
8.Effectively strengthening governance and deepening reform of the administrative system We proceeded with the reform of government agencies and put in place the basic institutional framework for establishing larger government departments that integrate the functions smaller ones had performed.We always observed the following basic norms in exercising governance: making policy decisions scientifically and democratically, conducting administration in accordance with the law, promoting transparency in government operations, improving the oversight system and upholding integrity.We adopted new measures and made new progress in exercising government power according to due procedures and in building a service-oriented, accountable, law-based and clean government.We took the following steps to improve government decision-making procedures: making policy decisions scientifically and democratically in accordance with the law;soliciting opinions from the public;and conducting expert evaluation, risk assessment, legality review, and collective discussion.We deepened reform of the system of review and approval by government bodies and eliminated or streamlined 498 items requiring such review and approval in two stages over the past five years.Departments of the State Council eliminated or streamlined 2,497 items requiring their review and approval, 69.3% of the original total.We took major steps to increase transparency in government operations, with the focus on government budgets and final accounts, as well as on expenditures for official hospitality, purchase and use of official cars, and overseas trips for official purposes.This made it possible for the people to learn more about how the government functions, and thus more effectively oversee its operations.Auditing oversight was intensified and became more effective.We comprehensively intensified efforts to fight corruption and build a clean government, and strengthened oversight and supervision of leading officials to ensure that they maintain personal integrity and are self-disciplined.We took steps to put in place a system of performance-based management of government officials, established and earnestly enforced the system of governance accountability focusing on leading government officials, and improved efficiency in governance.各位代表!
五年來,我們貫徹民族區(qū)域自治法,支持少數(shù)民族和民族地區(qū)發(fā)展的政策體系更加完善,民族團(tuán)結(jié)進(jìn)步事業(yè)煥發(fā)出新的蓬勃生機(jī)。
全面落實(shí)宗教信仰自由政策,宗教事務(wù)管理的法制化、規(guī)范化水平進(jìn)一步提升。認(rèn)真貫徹僑務(wù)政策,依法保護(hù)海外僑胞和歸僑僑眷的合法權(quán)益,僑務(wù)資源的獨(dú)特優(yōu)勢得到進(jìn)一步發(fā)揮。國防和軍隊(duì)建設(shè)開創(chuàng)新局面。中國特色軍事變革取得重大成就,軍隊(duì)革命化現(xiàn)代化正規(guī)化建設(shè)協(xié)調(diào)推進(jìn)、全面加強(qiáng),軍事斗爭準(zhǔn)備不斷深化,履行新世紀(jì)新階段歷史使命能力顯著增強(qiáng),出色完成一系列急難險(xiǎn)重任務(wù)。
港澳臺工作進(jìn)一步加強(qiáng)。香港、澳門保持繁榮穩(wěn)定,同內(nèi)地交流合作提高到新水平。推動(dòng)兩岸關(guān)系實(shí)現(xiàn)重大轉(zhuǎn)折,兩岸直接雙向“三通”全面實(shí)現(xiàn),簽署實(shí)施兩岸經(jīng)濟(jì)合作框架協(xié)議,形成兩岸全方位交往格局,開創(chuàng)兩岸關(guān)系和平發(fā)展新局面。
全方位外交取得新的重大進(jìn)展。我們積極推進(jìn)同各大國關(guān)系,加強(qiáng)與周邊鄰國的互利合作關(guān)系,順利建成中國-東盟自貿(mào)區(qū),推動(dòng)上海合作組織等區(qū)域合作機(jī)制發(fā)展,深化同廣大發(fā)展中國家的傳統(tǒng)友誼與合作,積極參與應(yīng)對國際金融危機(jī)、氣候變化等全球性問題的國際合作,推動(dòng)解決國際和地區(qū)熱點(diǎn)問題,為我國改革發(fā)展穩(wěn)定營造了有利的國際環(huán)境,為世界和平穩(wěn)定發(fā)展繁榮作出重要貢獻(xiàn)。Fellow Deputies, Over the past five years, we implemented the Law on Regional Ethnic Autonomy, improved the policy system for supporting the development of ethnic minorities and ethnic minority areas, and infused new vitality into the cause of promoting unity and progress of ethnic groups in China.We comprehensively carried out the policy on freedom of religious belief and managed religious affairs on a more law-and procedure-based basis.We implemented the policy on overseas Chinese affairs in both letter and spirit, protected the legitimate rights and interests of overseas Chinese and those who have returned to China and their families;and we put their unique strengths to better use.New progress was made in strengthening national defense and the armed forces.Major achievements were made in the revolution in military affairs with Chinese characteristics.The armed forces made coordinated and all-around progress in becoming more revolutionary, modernized and procedure-based.They deepened their military preparedness, greatly enhanced their ability to carry out their historic mission in the new stage in the new century, and accomplished a number of urgent, difficult, and hazardous tasks.We strengthened our work related to Hong Kong, Macao and Taiwan.Hong Kong and Macao are thriving and stable, and their exchanges and cooperation with the mainland reached a new height.We achieved a major transition in relations between the two sides of the Taiwan Straits.Complete, direct and two-way links of mail service, transport and trade were established, and the Economic Cooperation Framework Agreement was signed and is being implemented.This extended cross-Straits exchanges to all areas and ushered in a new stage of peaceful growth of cross-Straits relations.Major new progress was made in China's all-around diplomacy.We vigorously developed our relations with other major countries, enhanced mutually beneficial cooperation with our neighbors, and successfully established the China-ASEAN Free Trade Area.We spurred the development of the Shanghai Cooperation Organization and other mechanisms for promoting regional cooperation, and deepened our traditional friendship and cooperation with other developing countries.We actively participated in international cooperation on global issues like the global financial crisis and climate change and helped resolve international and regional hotspot issues.We thus fostered an international environment favorable for China's reform, development and stability and made a significant contribution to world peace, stability, development and prosperity.二、今年經(jīng)濟(jì)社會(huì)發(fā)展的總體要求、主要預(yù)期目標(biāo)和宏觀經(jīng)濟(jì)政策
II.General Requirements, Major Targets and Macroeconomic Policies for This Year's Economic and Social Development
黨的十八大科學(xué)總結(jié)了過去五年的工作和黨的十六大以來的奮斗歷程和歷史性成就,確定了全面建成小康社會(huì)和全面深化改革開放的目標(biāo),對進(jìn)一步推進(jìn)中國特色社會(huì)主義事業(yè)作出了全面部署。
2013年是全面貫徹落實(shí)黨的十八大精神的開局之年,是實(shí)施“十二五”規(guī)劃承前啟后的關(guān)鍵一年,是為全面建成小康社會(huì)奠定堅(jiān)實(shí)基礎(chǔ)的重要一年。我國發(fā)展仍處于可以大有作為的重要戰(zhàn)略機(jī)遇期,經(jīng)濟(jì)社會(huì)發(fā)展具備很多有利條件和積極因素,也面臨不少風(fēng)險(xiǎn)和挑戰(zhàn)。國際金融危機(jī)深層次影響持續(xù)顯現(xiàn),世界經(jīng)濟(jì)復(fù)蘇充滿不確定性、不穩(wěn)定性。我們既要看到形勢的積極方面,堅(jiān)定信心,也要看到形勢的復(fù)雜性,增強(qiáng)憂患意識和緊迫感,兢兢業(yè)業(yè)、扎扎實(shí)實(shí)做好工作。
今年工作的總體要求是:深入學(xué)習(xí)和全面貫徹落實(shí)黨的十八大精神,高舉中國特色社會(huì)主義偉大旗幟,以鄧小平理論、“三個(gè)代表”重要思想、科學(xué)發(fā)展觀為指導(dǎo),緊緊圍繞主題主線,以提高經(jīng)濟(jì)增長質(zhì)量和效益為中心,深化改革開放,實(shí)施創(chuàng)新驅(qū)動(dòng)戰(zhàn)略,穩(wěn)中求進(jìn),開拓創(chuàng)新,扎實(shí)開局,全面推進(jìn)社會(huì)主義經(jīng)濟(jì)建設(shè)、政治建設(shè)、文化建設(shè)、社會(huì)建設(shè)、生態(tài)文明建設(shè),實(shí)現(xiàn)經(jīng)濟(jì)持續(xù)健康發(fā)展和社會(huì)和諧穩(wěn)定。
今年經(jīng)濟(jì)社會(huì)發(fā)展的主要預(yù)期目標(biāo)是:國內(nèi)生產(chǎn)總值增長7.5%左右,發(fā)展的協(xié)調(diào)性進(jìn)一步增強(qiáng);居民消費(fèi)價(jià)格漲幅3.5%左右;城鎮(zhèn)新增就業(yè)900萬人以上,城鎮(zhèn)登記失業(yè)率低于4.6%;城鄉(xiāng)居民人均收入實(shí)際增長與經(jīng)濟(jì)增長同步,勞動(dòng)報(bào)酬增長和勞動(dòng)生產(chǎn)率提高同步;國際收支狀況進(jìn)一步改善。這里,著重對經(jīng)濟(jì)增長和物價(jià)總水平兩個(gè)指標(biāo)作些說明。關(guān)于經(jīng)濟(jì)增長目標(biāo)。這是一個(gè)綜合性指標(biāo),各方面高度關(guān)注。今年經(jīng)濟(jì)增長預(yù)期目標(biāo)定為7.5%左右,主要基于兩方面考慮:一方面,要繼續(xù)抓住機(jī)遇、促進(jìn)發(fā)展。這些年,我國制造業(yè)積累了較大產(chǎn)能,基礎(chǔ)設(shè)施狀況大為改善,支撐能力明顯增強(qiáng),儲蓄率較高,勞動(dòng)力總量仍然很大。必須優(yōu)化配置和利用生產(chǎn)要素,保持合理的增長速度,為增加就業(yè)、改善民生提供必要條件,為轉(zhuǎn)方式、調(diào)結(jié)構(gòu)創(chuàng)造穩(wěn)定環(huán)境;必須使經(jīng)濟(jì)增長與潛在增長率相協(xié)調(diào),與生產(chǎn)要素的供給能力和資源環(huán)境的承受能力相適應(yīng)。另一方面,要切實(shí)按照科學(xué)發(fā)展觀的要求,引導(dǎo)各方面把工作重心放到加快轉(zhuǎn)變經(jīng)濟(jì)發(fā)展方式和調(diào)整經(jīng)濟(jì)結(jié)構(gòu)上,放到提高經(jīng)濟(jì)增長的質(zhì)量和效益上,推動(dòng)經(jīng)濟(jì)持續(xù)健康發(fā)展。綜合權(quán)衡,今年的經(jīng)濟(jì)增長目標(biāo)定為7.5%左右是必要的、適宜的,實(shí)現(xiàn)這個(gè)目標(biāo)需要付出艱苦努力。
關(guān)于物價(jià)總水平。保持物價(jià)總水平基本穩(wěn)定始終是宏觀調(diào)控的重要目標(biāo)。去年居民消費(fèi)價(jià)格漲幅回落到2.6%,這是我們控制通貨膨脹取得的一個(gè)重要成果,也與經(jīng)濟(jì)運(yùn)行整體態(tài)勢有關(guān)。今年通貨膨脹壓力仍然較大,主要是:我國土地、勞動(dòng)力等要素價(jià)格,農(nóng)產(chǎn)品和服務(wù)類價(jià)格都存在上漲壓力;主要發(fā)達(dá)國家實(shí)行寬松貨幣政策并不斷加碼,輸入性通貨膨脹壓力不容忽視;理順能源資源價(jià)格需要留出一定空間;去年價(jià)格上漲的翹尾影響約有1個(gè)百分點(diǎn)。把居民消費(fèi)價(jià)格漲幅控制在3.5%左右,是充分考慮各方面因素后作出的選擇。要切實(shí)保障重要商品供給,搞活流通,降低物流成本,加強(qiáng)市場價(jià)格監(jiān)管,保持物價(jià)總水平基本穩(wěn)定。
實(shí)現(xiàn)上述目標(biāo),必須繼續(xù)實(shí)施積極的財(cái)政政策和穩(wěn)健的貨幣政策,保持政策連續(xù)性和穩(wěn)定性,增強(qiáng)前瞻性、針對性和靈活性。
繼續(xù)實(shí)施積極的財(cái)政政策。更好地發(fā)揮積極財(cái)政政策在穩(wěn)增長、調(diào)結(jié)構(gòu)、促改革、惠民生中的作用。一是適當(dāng)增加財(cái)政赤字和國債規(guī)模。今年擬安排財(cái)政赤字1.2萬億元,比去年預(yù)算增加4000億元,其中中央財(cái)政赤字8500億元,代地方發(fā)債3500億元。這主要是考慮到結(jié)構(gòu)性減稅的滯后效應(yīng),今年財(cái)政收入增長不會(huì)太快,但財(cái)政剛性支出增加,特別是要增加保障改善民生支出,保持對經(jīng)濟(jì)增長和結(jié)構(gòu)調(diào)整的支持力度,適當(dāng)擴(kuò)大財(cái)政赤字和國債規(guī)模是必要的。同時(shí),目前我國債務(wù)負(fù)擔(dān)率相對較低,今年增加赤字后,赤字率在2%左右,總體上處于安全水平。二是結(jié)合稅制改革完善結(jié)構(gòu)性減稅政策。重點(diǎn)是加快推進(jìn)營業(yè)稅改征增值稅試點(diǎn)工作,完善試點(diǎn)辦法,適時(shí)擴(kuò)大試點(diǎn)地區(qū)和行業(yè)范圍。三是著力優(yōu)化財(cái)政支出結(jié)構(gòu)。繼續(xù)向教育、醫(yī)藥衛(wèi)生、社會(huì)保障等民生領(lǐng)域和薄弱環(huán)節(jié)傾斜,嚴(yán)格控制行政經(jīng)費(fèi)等一般性支出,勤儉辦一切事業(yè)。中央預(yù)算內(nèi)投資主要投向保障性安居工程,農(nóng)業(yè)、水利、城市管網(wǎng)等基礎(chǔ)設(shè)施,社會(huì)事業(yè)等民生工程,節(jié)能減排和生態(tài)環(huán)境等領(lǐng)域。四是繼續(xù)加強(qiáng)地方政府性債務(wù)管理。妥善處理債務(wù)償還和在建項(xiàng)目后續(xù)融資問題,積極推進(jìn)地方政府性債務(wù)管理制度建設(shè),合理控制地方政府性債務(wù)水平。
繼續(xù)實(shí)施穩(wěn)健的貨幣政策。把握好促進(jìn)經(jīng)濟(jì)增長、穩(wěn)定物價(jià)和防范金融風(fēng)險(xiǎn)之間的平衡。一是健全宏觀審慎政策框架,發(fā)揮貨幣政策逆周期調(diào)節(jié)作用。廣義貨幣M2預(yù)期增長目標(biāo)擬定為13%左右。綜合運(yùn)用多種貨幣政策工具,調(diào)節(jié)市場流動(dòng)性,保持貨幣信貸合理增長,適當(dāng)擴(kuò)大社會(huì)融資規(guī)模。完善貨幣政策傳導(dǎo)機(jī)制,加強(qiáng)金融監(jiān)管與貨幣政策的協(xié)調(diào),不斷優(yōu)化監(jiān)管標(biāo)準(zhǔn)和監(jiān)管方式。二是促進(jìn)金融資源優(yōu)化配置。引導(dǎo)金融機(jī)構(gòu)加大對經(jīng)濟(jì)結(jié)構(gòu)調(diào)整特別是“三農(nóng)”、小微企業(yè)、戰(zhàn)略性新興產(chǎn)業(yè)等的金融支持,滿足國家重點(diǎn)在建續(xù)建項(xiàng)目資金需求。拓寬實(shí)體經(jīng)濟(jì)融資渠道,降低實(shí)體經(jīng)濟(jì)融資成本。促進(jìn)資本市場穩(wěn)定健康發(fā)展。三是守住不發(fā)生系統(tǒng)性和區(qū)域性金融風(fēng)險(xiǎn)底線。引導(dǎo)金融機(jī)構(gòu)穩(wěn)健經(jīng)營,加強(qiáng)對局部和區(qū)域性風(fēng)險(xiǎn)以及金融機(jī)構(gòu)表外業(yè)務(wù)風(fēng)險(xiǎn)的監(jiān)管,提高金融支持經(jīng)濟(jì)發(fā)展的可持續(xù)性。At its Eighteenth National Congress, the Party scientifically reviewed its work over the previous five years and the historic achievements since its Sixteenth Congress, set forth the objectives of finishing building a moderately prosperous society in all respects and deepening reform and opening up in an all-around way, and laid out an overall plan for advancing the cause of socialism with Chinese characteristics.The year 2013 is the first year for fully carrying out the guiding principles of the Party's Eighteenth National Congress, a crucial year for continuing to implement the Twelfth Five-Year Plan and an important year for laying a solid foundation for finishing building a moderately prosperous society in all respects.China remains in an important period of strategic opportunities during which much can be accomplished.There are many favorable conditions and positive factors as well as a number of risks and challenges for China's economic and social development.The profound impact of the global financial crisis persists, and the recovery of the world economy is full of uncertainty and not yet on a stable footing.We should realize that the situation is encouraging and so remain confident;but also that it is complex and so be mindful of adversity, have a keen sense of urgency, and industriously and earnestly do our work well.The general requirements for this year's work are:--Thoroughly study and fully implement the guiding principles of the Eighteenth Party Congress.--Hold high the great banner of socialism with Chinese characteristics.--Follow the guidance of Deng Xiaoping Theory, the important thought of Three Represents and the Scientific Outlook on Development.--Take developing in a scientific way as the underlying guideline and accelerating the change of the growth model as the major task.--Focus on improving the quality and performance of economic growth.--Deepen reform and opening up.--Implement the strategy of making development more innovation-driven.--Make progress while ensuring stability.--Blaze new trails in a pioneering spirit.--Get off to a good start.--Comprehensively promote socialist economic, political, cultural, social and ecological progress.--Achieve sustained, healthy economic growth and social harmony and stability.The major targets for this year's economic and social development are:--Increase GDP by about 7.5%.--Better coordinate development.--Hold increases in the CPI to around 3.5%.--Add more than 9 million urban jobs.--Keep the registered urban unemployment rate at or below 4.6%.--Ensure that real per capita income for urban and rural residents increases in step with economic growth and that work remuneration rises in step with increases in labor productivity.--Further improve the balance of payments.Here, I wish to explain our targets for economic growth and overall prices.The target for economic growth: This is a general target that is followed closely by all.In setting this year's target for economic growth at about 7.5%, we have taken two factors into account.On the one hand, we need to continue to seize opportunities and promote development.Over the years, the capacity of China's manufacturing industry has increased considerably and our infrastructure has improved significantly, which means they are better able to sustain development.The rate of savings has been high, and the size of the workforce has remained large.We must better allocate and employ factors of production and maintain a proper level of economic growth in order to provide necessary conditions for creating jobs and improving people's wellbeing and to create a stable environment for changing the growth model and adjusting the economic structure.We must ensure that economic growth is in accord with the potential economic growth rate, the ability to supply factors of production, and the bearing capacity of resources and the environment.On the other hand, we should, in accordance with the Scientific Outlook on Development, guide all the people to shift the focus of their work to accelerating the change of the growth model, adjusting the economic structure and improving the quality and performance of economic growth, so as to promote sustained and healthy economic development.In light of these considerations, we deem it necessary and appropriate to set this year's target for economic growth at about 7.5%, a goal that we will have to work hard to attain.The target for overall prices: Maintaining basic stability of overall prices has always been an important macro-control target.Last year, the rise in the CPI dropped to 2.6%.This was an important result of our efforts to curb inflation, and it was also due to the overall economic performance.This year, China is still under considerable inflationary pressure.The main reasons are:--There is upward pressure on the prices of land, labor and other factors of production and the prices of farm products and services.--Major developed countries are increasingly carrying out easy monetary policies, and imported inflationary pressure cannot be overlooked.--We need to leave some room for adjusting the prices of energy and resources.--The carry-over effect of the CPI increase in 2012 will contribute roughly one percentage point to this year's CPI growth rate.Taking all these factors fully into account, we have set the target for increases in the CPI at around 3.5% for this year.We should effectively ensure the supply of major commodities, boost distribution of goods, reduce logistics costs, tighten oversight over market prices, and keep overall prices basically stable.To reach the above targets, we must continue to implement a proactive fiscal policy and a prudent monetary policy, maintain continuity and stability of our policies, and make them more forward-looking, targeted and flexible.We will continue to implement a proactive fiscal policy.We should make our proactive fiscal policy play a bigger role in ensuring steady growth, adjusting the structure, advancing reform, and benefiting the people.First, we will increase the deficit and government debt by appropriate amounts.This year we are projecting a deficit of 1.2 trillion yuan, 400 billion more than the budgeted figure last year.This consists of a central government deficit of 850 billion yuan and 350 billion yuan in bonds to be issued on behalf of local governments.The time-lag of past structural tax cuts will make it hard for government revenue to grow fast this year, while fixed government expenditures will increase.In particular, it is necessary to increase spending to ensure and improve people's wellbeing and maintain support for economic growth and structural adjustment.Consequently, we deem it necessary to appropriately increase the deficit and government debt.It should be noted that China has a relatively low debt-to-GDP ratio, and the increase in the deficit this year will bring the deficit-to-GDP ratio to about 2%, which is overall at a safe level.Second, we will improve the structural tax cut policy as we continue to reform the tax system.The focus will be on accelerating the pilot project to replace business tax with VAT, improving the way these trials are conducted and extending them to more areas and sectors in a timely manner.Third, we will work hard to optimize the structure of government expenditures.We will continue to give priority to spending on education, medical and health care, social security and other weak areas that are important to people's wellbeing.We will strictly limit regular expenditures like administrative expenses, and practice thrift in everything we do.Investment from the central government budget will be mainly made in government-subsidized housing projects;infrastructure projects related to agriculture, water conservancy and urban utilities networks;social programs and other projects to improve people's wellbeing;and energy conservation, emissions reduction and environmental protection.Fourth, we will continue to strengthen management of local government debt.We will properly handle debt repayment and follow-up financing for ongoing projects, put in place a system for managing local government debt and keep such debt at an appropriate level.We will continue to implement a prudent monetary policy.We will maintain a balance between boosting economic growth, keeping prices stable and guarding against financial risks.First, we will improve the policy framework for exercising macro-control prudently and have monetary policy play the role of making counter-cyclic adjustments.The target for growth of the broad money supply(M2)is about 13%.We will employ a full range of monetary policy tools to control market liquidity, increase the money and credit supply at an appropriate pace, and expand the aggregate financing for the economy by an appropriate amount.We will improve the transmission mechanism for monetary policy, better coordinate financial oversight and monetary policy, and improve oversight standards and their implementation.Second, we will better allocate financial resources.We will guide financial institutions to increase financial support for structural adjustments to the economy, especially for agriculture, rural areas and farmers, small and micro businesses, and strategic emerging industries, and satisfy funding needs for key national projects under construction or expansion.We will broaden financing channels for the real economy and reduce its financing costs.We will promote steady and healthy development of the capital market.Third, we will resolutely guard against systemic and regional financial risks.We will guide financial institutions to operate prudently, and we will tighten oversight over financial risks in certain sectors and regions and risks related to the off-balance sheet activities of financial institutions, and thus make the financial sector's support for economic development more sustainable.三、對今年政府工作的建議
III.Suggestions for the Work of the Government This Year
結(jié)合過去十年特別是近五年工作的體會(huì),對今年政府主要工作提出以下建議。
Based on an understanding of the work of the past ten years, especially of the past five years, I wish to make the following suggestions for the government's main work this year.(一)加快轉(zhuǎn)變經(jīng)濟(jì)發(fā)展方式,促進(jìn)經(jīng)濟(jì)持續(xù)健康發(fā)展。我國社會(huì)主義現(xiàn)代化建設(shè)取得的一切成就都建立在經(jīng)濟(jì)持續(xù)健康發(fā)展的基礎(chǔ)之上,經(jīng)濟(jì)不發(fā)展,什么事情都辦不成。我國仍處于并將長期處于社會(huì)主義初級階段的基本國情沒有變,人民日益增長的物質(zhì)文化需要同落后的社會(huì)生產(chǎn)之間的矛盾這一社會(huì)主要矛盾沒有變,我國是世界上最大發(fā)展中國家的國際地位沒有變,發(fā)展仍是解決我國所有問題的關(guān)鍵。必須堅(jiān)持以經(jīng)濟(jì)建設(shè)為中心,聚精會(huì)神搞建設(shè),一心一意謀發(fā)展。只要我們牢牢把握發(fā)展的重要戰(zhàn)略機(jī)遇期,尊重發(fā)展規(guī)律,創(chuàng)新發(fā)展理念,破解發(fā)展難題,加快轉(zhuǎn)變經(jīng)濟(jì)發(fā)展方式,在發(fā)展中促轉(zhuǎn)變,在轉(zhuǎn)變中謀發(fā)展,就一定能實(shí)現(xiàn)經(jīng)濟(jì)持續(xù)健康發(fā)展。要堅(jiān)定不移地把擴(kuò)大內(nèi)需作為經(jīng)濟(jì)發(fā)展的長期戰(zhàn)略方針,充分發(fā)揮消費(fèi)的基礎(chǔ)作用和投資的關(guān)鍵作用。擴(kuò)大內(nèi)需的難點(diǎn)和重點(diǎn)在消費(fèi),潛力也在消費(fèi)。擴(kuò)大居民消費(fèi)要在提高消費(fèi)能力、穩(wěn)定消費(fèi)預(yù)期、增強(qiáng)消費(fèi)意愿、改善消費(fèi)環(huán)境上下功夫,不斷提高消費(fèi)對經(jīng)濟(jì)增長的拉動(dòng)力。現(xiàn)階段,投資在促進(jìn)經(jīng)濟(jì)增長中的作用不可低估。我國既有投資能力,又有投資需求,關(guān)鍵在于選準(zhǔn)方向、優(yōu)化結(jié)構(gòu)、提高投資的質(zhì)量和效益。政府投資對社會(huì)投資具有十分重要的引導(dǎo)作用,但占全社會(huì)投資的比重越來越小,必須進(jìn)一步放寬民間投資市場準(zhǔn)入,激發(fā)民間投資活力。
要大力推進(jìn)轉(zhuǎn)變經(jīng)濟(jì)發(fā)展方式,加快產(chǎn)業(yè)結(jié)構(gòu)調(diào)整。我國生產(chǎn)力發(fā)展水平具有多層次性,回旋余地很大,無論傳統(tǒng)產(chǎn)業(yè)還是新興產(chǎn)業(yè)、勞動(dòng)密集型產(chǎn)業(yè)還是資金密集型產(chǎn)業(yè),都有發(fā)展的空間,重要的是優(yōu)化資源配置和產(chǎn)業(yè)布局,解決產(chǎn)能過剩、核心技術(shù)缺乏、產(chǎn)品附加值低的問題,解決低水平重復(fù)建設(shè)和地區(qū)產(chǎn)業(yè)結(jié)構(gòu)趨同的問題。必須加快改造提升傳統(tǒng)產(chǎn)業(yè),大力發(fā)展高新技術(shù)產(chǎn)業(yè),提高產(chǎn)品質(zhì)量和市場競爭力。要加強(qiáng)政策引導(dǎo),鼓勵(lì)企業(yè)跨行業(yè)跨區(qū)域跨所有制兼并重組,利用市場倒逼機(jī)制促進(jìn)優(yōu)勝劣汰。以擴(kuò)大國內(nèi)市場應(yīng)用、重要關(guān)鍵技術(shù)攻關(guān)為重點(diǎn),推動(dòng)戰(zhàn)略性新興產(chǎn)業(yè)健康發(fā)展。積極推動(dòng)信息化和工業(yè)化融合,加快建設(shè)新一代信息基礎(chǔ)設(shè)施,促進(jìn)信息網(wǎng)絡(luò)技術(shù)廣泛應(yīng)用。堅(jiān)持生產(chǎn)性服務(wù)業(yè)和生活性服務(wù)業(yè)并重,現(xiàn)代服務(wù)業(yè)和傳統(tǒng)服務(wù)業(yè)并舉,進(jìn)一步發(fā)展壯大服務(wù)業(yè)。
要順應(yīng)人民群眾對美好生活環(huán)境的期待,大力加強(qiáng)生態(tài)文明建設(shè)和環(huán)境保護(hù)。生態(tài)環(huán)境關(guān)系人民福祉,關(guān)乎子孫后代和民族未來。要堅(jiān)持節(jié)約資源和保護(hù)環(huán)境的基本國策,著力推進(jìn)綠色發(fā)展、循環(huán)發(fā)展、低碳發(fā)展。大力推進(jìn)能源資源節(jié)約和循環(huán)利用,重點(diǎn)抓好工業(yè)、交通、建筑、公共機(jī)構(gòu)等領(lǐng)域節(jié)能,控制能源消費(fèi)總量,降低能耗、物耗和二氧化碳排放強(qiáng)度。要加快調(diào)整經(jīng)濟(jì)結(jié)構(gòu)和布局,抓緊完善標(biāo)準(zhǔn)、制度和法規(guī)體系,采取切實(shí)的防治污染措施,促進(jìn)生產(chǎn)方式和生活方式的轉(zhuǎn)變,下決心解決好關(guān)系群眾切身利益的大氣、水、土壤等突出環(huán)境污染問題,改善環(huán)境質(zhì)量,維護(hù)人民健康,用實(shí)際行動(dòng)和成效讓人民看到希望。要做好氣象、地質(zhì)、地震等方面工作,提高防災(zāi)減災(zāi)能力。優(yōu)化國土空間開發(fā)格局,合理控制開發(fā)強(qiáng)度,調(diào)整空間結(jié)構(gòu)。加強(qiáng)海洋綜合管理,發(fā)展海洋經(jīng)濟(jì),提高海洋資源開發(fā)能力,保護(hù)海洋生態(tài)環(huán)境,維護(hù)國家海洋權(quán)益。
要繼續(xù)深入實(shí)施區(qū)域發(fā)展總體戰(zhàn)略,促進(jìn)區(qū)域經(jīng)濟(jì)協(xié)調(diào)發(fā)展。充分發(fā)揮各地比較優(yōu)勢,統(tǒng)籌規(guī)劃、分類指導(dǎo),優(yōu)先推進(jìn)西部大開發(fā),全面振興東北地區(qū)等老工業(yè)基地,大力促進(jìn)中部地區(qū)崛起,積極支持東部地區(qū)率先發(fā)展,加大對革命老區(qū)、民族地區(qū)、邊疆地區(qū)、貧困地區(qū)扶持力度,深入推進(jìn)集中連片特殊困難地區(qū)扶貧攻堅(jiān)。
1.Accelerating the change of the growth model and promoting sustained and sound economic development All the achievements we have made in China's socialist modernization are attributable to sustained and sound economic development, without which we would have accomplished nothing.China is still in the primary stage of socialism and will remain so for a long time.This basic national condition has not changed;nor has the principal problem in our society, that is, production falls short of the ever-growing material and cultural needs of the people, or China's international position as the largest developing country in the world.Development is still the key to solving all our problems.We must keep economic development as the central task and give it our undivided attention.As long as we make full use of this important period of strategic opportunities, respect the law of development, formulate new thinking on development, solve problems hindering development, accelerate the change of the growth model, spur change in the course of pursuing development, and promote development while working for change, we can certainly achieve sustained and sound economic development.We should unswervingly take expanding domestic demand as our long-term strategy for economic development, and make full use of the basic function of consumption and the key role of investment.The difficulty in and key to expanding domestic demand lie in consumption, and that is also where the potential lies.To expand individual consumption, we should enhance people's ability to consume, keep their consumption expectations stable, boost their desire to consume, improve the consumption environment and make economic growth more consumption-driven.In the current stage, the role investment plays in promoting economic growth cannot be underestimated.China has both investment capability and investment demand, but the key is to make investment in the needed sectors, optimize the structure of investment, and improve its performance and returns.Governmental investment is important in guiding nongovernmental investment, but its share of the country's total investment is decreasing, so we must further relax controls over market access for nongovernmental investment and stimulate it.We should energetically change the growth model and speed up structural adjustment of industry.China's productive forces develop on multiple levels, which gives us plenty of room to maneuver.Industries, whether traditional or emerging, labor-intensive or capital-intensive, all have room for development.The important task is to optimize resources allocation and industrial distribution, and solve the following problems: excess production capacity, the lack of core technology, products with low value-added, low-level and redundant industrial projects, and different regions having similar industrial structures.We must accelerate the transformation and upgrading of traditional industries, energetically develop new-and high-tech industries, and raise product quality and competitiveness.We should strengthen policy guidance;encourage enterprise acquisitions and reorganizations across industries, regions and forms of ownership;and allow market forces to determine enterprises' success or failure.We should promote sound development of strategic emerging industries, with the focus on expanding their share in the domestic market and making breakthroughs in major and key technologies.We should promote the integration of IT application and industrialization, more quickly build next-generation information and communication infrastructure, and spread the use of information network technology.We should develop and expand the service sector, and attach equal importance to producer and consumer service industries and to modern and traditional service industries.In response to people's expectations of having a good living environment, we should greatly strengthen ecological improvement and environmental protection.The state of the ecological environment affects the level of people's wellbeing and also posterity and the future of our nation.We should adhere to the basic state policy of conserving resources and protecting the environment and endeavor to promote green, circular, and low-carbon development.We should greatly boost the conservation and reuse of energy and resources, give priority to saving energy in industry, transportation and construction and in public institutions, restrict total energy consumption, and reduce energy and materials consumption and carbon dioxide emissions.We should speed up adjusting the economic structure and distribution and upgrading related standards, practices, and laws and regulations.We should adopt effective measures to prevent and control pollution and change the way we work and live.We should resolve to solve the problems of serious air, water, and soil pollution that affect the people's vital interests;improve environmental quality, and safeguard people's health, and give the people hope through our concrete action and achievements.We should do our meteorological, geological and seismic work well and become better able to prevent and mitigate natural disasters.We should optimize development of the country's territory, carry out development at a proper pace and adjust its spatial layout.We should strengthen comprehensive marine management, develop the marine economy, become better able to exploit marine resources, protect the marine ecological environment, and safeguard China's maritime rights and interests.We should continue to fully implement the master strategy for regional development and promote balanced development between regions.We should make full use of the comparative strengths of each region, make plans comprehensively and give guidance tailored to different circumstances.We should give high priority to large-scale development of the western region, fully revitalize the old industrial bases in northeast China, spur the rise of the central region, and support the eastern region in taking the lead in development.We should increase support for old revolutionary base areas, ethnic minority areas, border areas and poor areas and alleviate poverty in contiguous areas with acute difficulties.(二)強(qiáng)化農(nóng)業(yè)農(nóng)村發(fā)展基礎(chǔ),推動(dòng)城鄉(xiāng)發(fā)展一體化。近些年是我國農(nóng)業(yè)發(fā)展最快、農(nóng)村面貌變化最大、農(nóng)民得到實(shí)惠最多的時(shí)期。當(dāng)前,農(nóng)業(yè)農(nóng)村發(fā)展進(jìn)入一個(gè)新階段,呈現(xiàn)出農(nóng)業(yè)生產(chǎn)綜合成本上升、農(nóng)產(chǎn)品供求結(jié)構(gòu)性矛盾突出、農(nóng)村社會(huì)結(jié)構(gòu)深刻變動(dòng)、城鄉(xiāng)發(fā)展加快融合的態(tài)勢,全面建成小康社會(huì)的重點(diǎn)難點(diǎn)仍然在農(nóng)村。必須堅(jiān)持把解決好“三農(nóng)”問題作為全部工作的重中之重,這是歷史經(jīng)驗(yàn)的科學(xué)總結(jié),既管當(dāng)前,也管長遠(yuǎn),是長期指導(dǎo)思想。農(nóng)村土地制度關(guān)乎農(nóng)村的根本穩(wěn)定,也關(guān)乎中國的長遠(yuǎn)發(fā)展,其核心是要保障農(nóng)民的財(cái)產(chǎn)權(quán)益,底線是嚴(yán)守18億畝耕地紅線。要堅(jiān)持以家庭承包經(jīng)營為基礎(chǔ),支持發(fā)展多種形式新型農(nóng)民合作組織和多層次的農(nóng)業(yè)社會(huì)化服務(wù)組織,逐步構(gòu)建集約化、專業(yè)化、組織化、社會(huì)化相結(jié)合的新型農(nóng)業(yè)經(jīng)營體系,始終注重保護(hù)法律賦予農(nóng)民的財(cái)產(chǎn)權(quán)利,調(diào)動(dòng)農(nóng)民積極性。毫不放松糧食生產(chǎn),建設(shè)高標(biāo)準(zhǔn)基本農(nóng)田,推廣先進(jìn)技術(shù),增強(qiáng)農(nóng)業(yè)綜合生產(chǎn)能力,保障糧食和重要農(nóng)產(chǎn)品的有效供給。要繼續(xù)加大“三農(nóng)”投入,加強(qiáng)農(nóng)村基礎(chǔ)設(shè)施建設(shè)和基本公共服務(wù)體系建設(shè),推動(dòng)城鄉(xiāng)發(fā)展一體化,形成以工促農(nóng)、以城帶鄉(xiāng)、工農(nóng)互惠、城鄉(xiāng)一體的新型工農(nóng)、城鄉(xiāng)關(guān)系。要采取有效措施,穩(wěn)定農(nóng)業(yè)生產(chǎn)經(jīng)營隊(duì)伍,積極培育新型農(nóng)民。
城鎮(zhèn)化是我國現(xiàn)代化建設(shè)的歷史任務(wù),與農(nóng)業(yè)現(xiàn)代化相輔相成。要遵循城鎮(zhèn)化的客觀規(guī)律,積極穩(wěn)妥推動(dòng)城鎮(zhèn)化健康發(fā)展。堅(jiān)持科學(xué)規(guī)劃、合理布局、城鄉(xiāng)統(tǒng)籌、節(jié)約用地、因地制宜、提高質(zhì)量。特大城市和大城市要合理控制規(guī)模,充分發(fā)揮輻射帶動(dòng)作用;中小城市和小城鎮(zhèn)要增強(qiáng)產(chǎn)業(yè)發(fā)展、公共服務(wù)、吸納就業(yè)、人口集聚功能。加快推進(jìn)戶籍制度、社會(huì)管理體制和相關(guān)制度改革,有序推進(jìn)農(nóng)業(yè)轉(zhuǎn)移人口市民化,逐步實(shí)現(xiàn)城鎮(zhèn)基本公共服務(wù)覆蓋常住人口,為人們自由遷徙、安居樂業(yè)創(chuàng)造公平的制度環(huán)境。村莊建設(shè)要注意保持鄉(xiāng)村風(fēng)貌,營造宜居環(huán)境,使城鎮(zhèn)化和新農(nóng)村建設(shè)良性互動(dòng)。
2.Strengthening the foundation for agriculture and rural development and promoting integrated urban and rural development In recent years, China's agriculture has developed faster, its rural areas have undergone more significant changes, and its rural residents have received more tangible benefits than in any other period.Agriculture and rural development in China have now entered a new stage in which overall agricultural production costs are rising, structural problems in the supply and demand of agricultural products are worsening, the rural social structure is undergoing profound changes, and integration of urban and rural development is speeding up.All the major and difficult problems that we face in finishing building a moderately prosperous society in all respects are in rural areas.We must make solving issues relating to agriculture, rural areas and farmers the number one priority in all our work.This is a scientific conclusion drawn from our historical experience and a long-term guiding principle applicable to both the present and the future.The rural land system is central to maintaining rural stability and ensuring China's long-term development.Its main purpose is to guarantee farmers' property rights and interests, and its main objective is to ensure that China's farmland remains at or above the red line of 120 million hectares.We should continue to make household contracts the basis of rural operations, support the development of new farmers' cooperatives of various forms and multilevel commercial organizations that provide agricultural services, and gradually establish a new type of system of intensive agricultural operations that are specialized, well organized and commercialized.We should always protect farmers' legitimate property rights and keep them motivated.We should always give high priority to grain production, develop high-yield basic farmland, spread advanced technologies, increase overall agricultural production capacity, and effectively ensure the supply of grain and other important agricultural products.We should continue to increase spending on agriculture, rural areas and farmers;improve infrastructure and basic public services in rural areas;and promote integration of urban and rural development.We should build a new type of relations between industry and agriculture and between urban and rural areas in which industry promotes agriculture, urban areas support rural development, industry and agriculture reinforce each other, and urban development and rural development are integrated.We should take effective measures to keep the agricultural workforce stable and train a new type of farmers.Urbanization is a historical task in China's modernization drive, and urbanization and agricultural modernization complement each other.We should conform to the objective law of urbanization and carry it out actively yet prudently.We should promote sound development of urbanization by making plans scientifically, balancing geographical distribution, coordinating urban and rural development, using land economically, and tailoring measures to local conditions.Megacities and large cities should be kept at an appropriate scale and fully play their role in driving the development of their surrounding areas.Small and medium-sized cities and small towns should become better able to develop industries, provide public services, create jobs, and attract residents.We should accelerate reform of the household registration system, the social management system and related institutions;register eligible rural workers as permanent urban residents in an orderly manner;progressively expand the coverage of basic public services in urban areas to all their permanent residents;and create an equitable institutional environment for freedom of movement and for people to live and work in contentment.In improving village conditions, we should preserve their distinctive rural flavor, make their environment more livable, and ensure that urbanization and the building of a new countryside reinforce each other.(三)以保障和改善民生為重點(diǎn),全面提高人民物質(zhì)文化生活水平。2003年抗擊突如其來的非典疫情給我們的重要啟示之一,就是要統(tǒng)籌經(jīng)濟(jì)社會(huì)發(fā)展。這些年我們在發(fā)展經(jīng)濟(jì)的同時(shí),更加重視保障改善民生和發(fā)展社會(huì)事業(yè),政府工作力度之大、財(cái)政投入資金之多前所未有。經(jīng)過不懈努力,我國經(jīng)濟(jì)社會(huì)發(fā)展的協(xié)調(diào)性明顯增強(qiáng)。當(dāng)前社會(huì)結(jié)構(gòu)、社會(huì)組織形式、社會(huì)利益格局發(fā)生深刻變化,社會(huì)矛盾明顯增多。我們必須把保障和改善民生作為政府一切工作的出發(fā)點(diǎn)和落腳點(diǎn),放在更加突出的位置,著力加強(qiáng)社會(huì)建設(shè)。
千方百計(jì)擴(kuò)大就業(yè)。堅(jiān)持實(shí)施就業(yè)優(yōu)先戰(zhàn)略和更加積極的就業(yè)政策,通過穩(wěn)定經(jīng)濟(jì)增長和調(diào)整經(jīng)濟(jì)結(jié)構(gòu)增加就業(yè)崗位,加強(qiáng)職業(yè)技能培訓(xùn),提高勞動(dòng)者就業(yè)創(chuàng)業(yè)能力,加大投入和政策支持,完善就業(yè)服務(wù)體系,鼓勵(lì)創(chuàng)業(yè)帶動(dòng)就業(yè),做好重點(diǎn)人群就業(yè)工作,促進(jìn)城鄉(xiāng)居民收入持續(xù)穩(wěn)定增長。
完善社會(huì)保障制度。堅(jiān)持全覆蓋、?;尽⒍鄬哟?、可持續(xù)方針,不斷擴(kuò)大社會(huì)保障覆蓋面,提高統(tǒng)籌層次和保障水平,加強(qiáng)各項(xiàng)制度的完善和銜接,增強(qiáng)公平性,適應(yīng)流動(dòng)性,保證可持續(xù)性。今年企業(yè)退休人員基本養(yǎng)老金繼續(xù)提高10%,城鄉(xiāng)低保和優(yōu)撫對象補(bǔ)助標(biāo)準(zhǔn)也進(jìn)一步提高。要加大對社會(huì)養(yǎng)老服務(wù)體系和兒童福利機(jī)構(gòu)建設(shè)的支持力度。深化醫(yī)藥衛(wèi)生事業(yè)改革發(fā)展。鞏固完善基本藥物制度和基層醫(yī)療衛(wèi)生機(jī)構(gòu)運(yùn)行新機(jī)制,加快公立醫(yī)院改革,鼓勵(lì)社會(huì)辦醫(yī)。扶持中醫(yī)藥和民族醫(yī)藥事業(yè)發(fā)展。健全全民醫(yī)保體系,建立重特大疾病保障和救助機(jī)制,全面開展兒童白血病等20種重大疾病保障試點(diǎn)工作。今年新農(nóng)合和城鎮(zhèn)居民基本醫(yī)療保險(xiǎn)財(cái)政補(bǔ)助標(biāo)準(zhǔn)由每人每年240元提高到280元,人均基本公共衛(wèi)生服務(wù)經(jīng)費(fèi)標(biāo)準(zhǔn)由25元提高到30元。逐步完善人口政策。堅(jiān)持計(jì)劃生育基本國策,適應(yīng)我國人口總量和結(jié)構(gòu)變動(dòng)趨勢,統(tǒng)籌解決好人口數(shù)量、素質(zhì)、結(jié)構(gòu)和分布問題,促進(jìn)人口長期均衡發(fā)展。重視發(fā)展老齡事業(yè),切實(shí)保障婦女和未成年人權(quán)益,關(guān)心和支持殘疾人事業(yè)。
加強(qiáng)和創(chuàng)新社會(huì)管理。改進(jìn)政府提供公共服務(wù)方式,加強(qiáng)基層社會(huì)管理和服務(wù)體系建設(shè),完善村民自治、城市居民自治制度,保證人民群眾依法直接行使民主權(quán)利,管理基層公共事務(wù)和公益事業(yè)。改革社會(huì)組織管理體制,引導(dǎo)社會(huì)組織健康有序發(fā)展。建立健全維護(hù)群眾權(quán)益機(jī)制,完善人民調(diào)解、行政調(diào)解、司法調(diào)解聯(lián)動(dòng)的工作體系,健全法律援助制度,推動(dòng)涉法涉訴信訪工作改革,暢通和規(guī)范群眾訴求表達(dá)、利益協(xié)調(diào)、權(quán)益保障渠道,健全重大決策社會(huì)穩(wěn)定風(fēng)險(xiǎn)評估和突發(fā)事件應(yīng)急管理機(jī)制,維護(hù)社會(huì)公共安全,促進(jìn)社會(huì)和諧穩(wěn)定。食品藥品安全是人們關(guān)注的突出問題,要改革和健全食品藥品安全監(jiān)管體制,加強(qiáng)綜合協(xié)調(diào)聯(lián)動(dòng),落實(shí)企業(yè)主體責(zé)任,嚴(yán)格從生產(chǎn)源頭到消費(fèi)的全程監(jiān)管,加快形成符合國情、科學(xué)合理的食品藥品安全體系,提升食品藥品安全保障水平。強(qiáng)化公共安全體系和企業(yè)安全生產(chǎn)基礎(chǔ)建設(shè),遏制重特大安全事故。
加強(qiáng)房地產(chǎn)市場調(diào)控和保障性安居工程建設(shè)。堅(jiān)決抑制投機(jī)、投資性需求,抓緊完善穩(wěn)定房價(jià)工作責(zé)任制和房地產(chǎn)市場調(diào)控政策體系,健全房地產(chǎn)市場穩(wěn)定健康發(fā)展長效機(jī)制。繼續(xù)抓好保障性安居工程建設(shè)和管理,讓老百姓住上放心房、滿意房。今年城鎮(zhèn)保障性住房基本建成470萬套、新開工630萬套,繼續(xù)推進(jìn)農(nóng)村危房改造。
教育和科技在現(xiàn)代化建設(shè)中具有基礎(chǔ)性、先導(dǎo)性、全局性作用,文化是民族的血脈和人民的精神家園,必須放在更加重要的戰(zhàn)略位置。
繼續(xù)推進(jìn)教育優(yōu)先發(fā)展。目前我國財(cái)政性教育經(jīng)費(fèi)支出總額已經(jīng)超過2萬億元,今后還要繼續(xù)增加,必須把這些錢用好,讓人民滿意。要進(jìn)一步深化教育綜合改革,切實(shí)解決社會(huì)普遍關(guān)注的重大問題。著力推動(dòng)義務(wù)教育均衡發(fā)展,加快發(fā)展現(xiàn)代職業(yè)教育,提高各級各類教育質(zhì)量,進(jìn)一步促進(jìn)教育公平,為國家發(fā)展提供強(qiáng)大的人力資源支撐。深化科技體制改革。推動(dòng)科技與經(jīng)濟(jì)緊密結(jié)合,著力構(gòu)建以企業(yè)為主體、市場為導(dǎo)向、產(chǎn)學(xué)研相結(jié)合的技術(shù)創(chuàng)新體系。瞄準(zhǔn)關(guān)系全局和長遠(yuǎn)發(fā)展的戰(zhàn)略必爭領(lǐng)域,加強(qiáng)基礎(chǔ)研究、前沿先導(dǎo)技術(shù)研究。健全科技資源開放共享機(jī)制,完善支持科技發(fā)展和成果應(yīng)用轉(zhuǎn)化的財(cái)稅、金融、產(chǎn)業(yè)技術(shù)和人才政策,創(chuàng)造公平開放的創(chuàng)新環(huán)境,最大限度地調(diào)動(dòng)廣大科技工作者的積極性、主動(dòng)性,激發(fā)全社會(huì)的創(chuàng)新活力。
扎實(shí)推進(jìn)文化建設(shè)。把文化改革發(fā)展納入經(jīng)濟(jì)社會(huì)發(fā)展總體規(guī)劃,列入各級政府效能和領(lǐng)導(dǎo)干部政績考核體系,推動(dòng)文化事業(yè)全面繁榮、文化產(chǎn)業(yè)快速發(fā)展。政府要履行好發(fā)展公益性文化事業(yè)的責(zé)任,加快推進(jìn)重點(diǎn)文化惠民工程,完善公共文化服務(wù)體系。廣泛開展全民健身運(yùn)動(dòng),促進(jìn)群眾體育和競技體育全面發(fā)展。
大力加強(qiáng)社會(huì)公德、職業(yè)道德、家庭美德、個(gè)人品德教育。推動(dòng)誠信體系建設(shè),以政務(wù)誠信帶動(dòng)商務(wù)誠信和社會(huì)誠信,形成良好的社會(huì)風(fēng)尚。
3.Giving high priority to ensuring and improving people's wellbeing and comprehensively improving their material and cultural lives An important lesson we learned in our response to the sudden outbreak of the severe acute respiratory syndrome(SARS)in 2003 is that economic development and social development need to be coordinated.In developing the economy in the years since then, we have placed greater importance on ensuring and improving people's wellbeing and developing social programs, and the government has made greater efforts and provided more funding in this area than ever before.These unremitting efforts have resulted in much better coordination of China's economic and social development.The structure of Chinese society, its forms of organization, and the pattern of interests in society have all undergone profound changes, and social problems have increased markedly.We must make ensuring and improving people's wellbeing the starting point and goal of all the government's work, give higher priority to it, and strive to strengthen social development.We should do all we can to increase employment.We should persevere in implementing the strategy of giving top priority to employment and adopt a more proactive employment policy.We should create more jobs by maintaining stable economic growth and adjusting the economic structure and provide better vocational skills training to help people to find jobs or start their own businesses.We should increase government spending and policy support, improve the employment services system, stimulate employment by encouraging business startups, assist target groups in finding jobs, and stimulate sustained, steady increases in urban and rural incomes.We should improve the social security system.We should continue to follow the policy of making coverage universal, ensuring basic care, and providing multilevel and sustainable social security.We should expand the coverage of social security, turn over the overall management of social security accounts to higher-level authorities, raise social security benefits, improve and coordinate all social security programs, make social security more equitable and sustainable, and facilitate the smooth transfer of social security accounts between localities.This year, basic old-age pensions for enterprise retirees should be raised by another 10%, and subsistence allowances for urban and rural residents and subsidies for entitled groups should also be further raised.Greater support should be given to developing child welfare agencies and the system of social services for the elderly.We should advance reform and development of medical and health care services, consolidate and improve the system for using basic drugs and the new operating mechanisms of community-level medical and health care institutions, speed up the reform of public hospitals, and encourage nongovernmental bodies to operate hospitals.We should support development of traditional Chinese medicine and ethnic minority medicine.We should improve the universal medical insurance system, establish a mechanism to provide insurance and aid for treating major and very serious diseases, and conduct a pilot project to insure against 20 serious diseases.(Note: They are childhood leukemia, congenital heart disease in children, uremia, breast cancer, cervical cancer, holergasia, drug-resistant tuberculosis, opportunistic AIDS and HIV infection, lung cancer, esophagus cancer, gastric cancer, colon cancer, rectal cancer, chronic myeloid leukemia, acute myocardial infarction, cerebral infarction, hemophilia, type 1 diabetes, hyperthyroidism, and cheilopalatognathus.)This year, annual government subsidies for the new rural cooperative medical care system and basic medical insurance for non-working urban residents should be raised from 240 yuan to 280 yuan per person respectively, and the per person payment standard for basic public health services should be increased from 25 yuan to 30 yuan.We should progressively improve the government population policy.We should adhere to the basic state policy on family planning.In response to changes in the size and structure of China's total population, we should comprehensively solve problems relating to the size, health, structure and geographical distribution of the population and promote long-term, balanced population development.We should boost the development of elderly services, protect the rights and interests of women and minors, and take an interest in and support programs that benefit people with disabilities.We should strengthen and make innovations in social management.We should improve the way the government provides public services, strengthen the system of social management and services at the community level, and improve self-governance by villagers and urban residents, to ensure that the people directly exercise their democratic rights in accordance with the law by managing community-level public affairs and running public service programs.We should reform the management system for social organizations, and guide their sound and orderly development.We should establish a sound mechanism for safeguarding people's rights and interests;improve the integrated system of mediation by the people, administrative mediation and judicial mediation;strengthen the system of legal assistance;and carry out reform of the handling of people's complaints about legal and litigation-related issues.We should maintain open and regular channels for people to voice their demands, and we should coordinate the people's interests and protect their rights and interests.We should improve the mechanism for assessing potential risks major policy decisions may pose to social stability and the emergency response mechanism.The purpose of all this work is to preserve law and order and promote social harmony and stability.Food and drug safety is a prominent issue of widespread concern.We should reform and improve mechanisms for overseeing and supervising food and drug safety and strengthen overall coordination.We should require enterprises to assume primary responsibility for safety, exercise strict oversight and supervision throughout the whole process from production to consumption, and move faster to establish a scientific and effective food and drug safety system that suits China's national conditions so as to better ensure food and drug safety.We should strengthen the public safety system and improve workplace safety conditions to prevent accidents, especially major and very serious ones.We should tighten regulation of the real estate market and strengthen construction of government-subsidized housing.We need to firmly rein in speculative and investment-driven housing demand, promptly improve the accountability system for stabilizing housing prices and the policies for regulating the real estate market, and strengthen mechanisms for sustaining its steady and sound development.We should continue to build and manage government-subsidized housing for the people so they have housing they are satisfied with.This year, 4.7 million government-subsidized urban housing units should be basically completed, construction of another 6.3 million units should begin, and renovation of dilapidated rural houses should continue.Education, science and technology play a fundamental, guiding and global role in the country's modernization drive, and culture is essential for the long-term vitality of a nation and gives the people a sense of belonging.They must therefore occupy a position of greater strategic importance.We should continue to give top priority to developing education.China's annual government expenditures on education already exceed two trillion yuan and should continue to increase.We must make good use of such funding to the satisfaction of the people.We need to deepen comprehensive education reform and effectively solve major issues of public concern.We should boost balanced development of compulsory education, accelerate development of modern vocational education and raise the quality of education of all types and at all levels.This should help make education more equitable and provide strong human resources support for China's development.We should deepen reform of the management system for science and technology.We should integrate science and technology more closely with the economy, and establish a technological innovation system that is based on enterprises, guided by the market, and integrates enterprises, universities and research institutes.We should focus on priority areas of strategic importance that are vital to China's overall and long-term development, and strengthen basic research and research on frontier and leading technologies.We should improve the mechanism for openly sharing scientific and technological resources and the fiscal, taxation, banking, industrial technology and personnel policies that support scientific and technological development and industrial application of scientific and technological advances, create a fair and open environment for making innovations, keep scientists and technicians fully motivated, and unleash the creativity of the whole society.We should effectively advance development of the cultural sector.We should incorporate reform and development of the cultural sector into general plans for economic and social development, and include them in the system for evaluating the performance of governments and officials at all levels so as to promote all-around cultural prosperity and fast development of the cultural sector.The government needs to fulfill its responsibility to develop nonprofit cultural programs, accelerate key cultural projects for the people, and improve the system of public cultural services.We should extensively carry out public fitness activities and promote comprehensive development of both recreational and competitive sports.We should greatly increase education in public morality, professional ethics, family virtues, and personal integrity.We should promote a creditability system, use political integrity to improve business and public integrity, and foster healthy social conduct.(四)以更大的政治勇氣和智慧,深入推進(jìn)改革開放。改革開放是國家發(fā)展進(jìn)步的根本動(dòng)力。只有堅(jiān)持改革開放,才能把我們的事業(yè)繼續(xù)推向前進(jìn)。我國改革已進(jìn)入攻堅(jiān)階段,必須進(jìn)一步解放思想,全面深化經(jīng)濟(jì)體制改革,繼續(xù)積極穩(wěn)妥推進(jìn)政治體制改革,深化文化體制改革,加快推進(jìn)社會(huì)體制改革,加強(qiáng)生態(tài)文明制度建設(shè),不斷把改革引向深入。要進(jìn)一步完善社會(huì)主義市場經(jīng)濟(jì)體制。毫不動(dòng)搖地鞏固和發(fā)展公有制經(jīng)濟(jì),毫不動(dòng)搖地鼓勵(lì)、支持、引導(dǎo)非公有制經(jīng)濟(jì)發(fā)展,形成各種所有制經(jīng)濟(jì)依法平等使用生產(chǎn)要素、公平參與市場競爭、同等受到法律保護(hù)的體制環(huán)境。深化國有企業(yè)改革以及重點(diǎn)行業(yè)改革。加快財(cái)稅體制改革,理順中央和地方財(cái)力與事權(quán)的關(guān)系,完善財(cái)政轉(zhuǎn)移支付制度,健全公共財(cái)政體系,構(gòu)建地方稅體系,促進(jìn)形成有利于結(jié)構(gòu)優(yōu)化、社會(huì)公平的稅收制度。深化金融體制改革,健全促進(jìn)實(shí)體經(jīng)濟(jì)發(fā)展的現(xiàn)代金融體系,提高銀行、證券、保險(xiǎn)等行業(yè)競爭力,加快發(fā)展多層次資本市場,積極發(fā)展債券市場,穩(wěn)步推進(jìn)利率、匯率市場化改革,擴(kuò)大人民幣跨境使用,逐步實(shí)現(xiàn)人民幣資本項(xiàng)目可兌換。深化投融資體制改革,推進(jìn)價(jià)格改革,健全資源性產(chǎn)品價(jià)格形成機(jī)制和生態(tài)補(bǔ)償制度。繼續(xù)積極穩(wěn)妥推進(jìn)事業(yè)單位分類改革。收入分配制度是經(jīng)濟(jì)社會(huì)發(fā)展中一項(xiàng)根本性、基礎(chǔ)性的制度,是社會(huì)主義市場經(jīng)濟(jì)體制的重要基石。我們已經(jīng)制定了深化收入分配制度改革若干意見,要抓緊研究制定具體政策,確保制度建設(shè)到位、政策落實(shí)到位,有效解決收入分配領(lǐng)域存在的問題,縮小收入分配差距,使發(fā)展成果更多更公平地惠及全體人民。
要推進(jìn)社會(huì)主義民主法治建設(shè)。堅(jiān)持人民主體地位,發(fā)展更加廣泛、更加充分、更加健全的人民民主,保證人民依法享有廣泛權(quán)利和自由,促進(jìn)人的全面發(fā)展,維護(hù)社會(huì)公平正義。堅(jiān)持依法治國,充分尊重憲法和法律的權(quán)威,確保決策權(quán)、執(zhí)行權(quán)、監(jiān)督權(quán)既相互制約又相互協(xié)調(diào),確保國家行政機(jī)關(guān)按照法定權(quán)限和程序行使權(quán)力。堅(jiān)持轉(zhuǎn)變政府職能,推進(jìn)政企分開、政資分開、政事分開、政社分開,建設(shè)職能科學(xué)、結(jié)構(gòu)優(yōu)化、廉潔高效、人民滿意的服務(wù)型政府。堅(jiān)持改進(jìn)工作作風(fēng)、密切聯(lián)系群眾,提倡艱苦奮斗,厲行勤儉節(jié)約,反對鋪張浪費(fèi),克服形式主義、官僚主義。堅(jiān)持民主監(jiān)督、法律監(jiān)督、輿論監(jiān)督,健全權(quán)力運(yùn)行制約和監(jiān)督體系,讓人民監(jiān)督權(quán)力,讓權(quán)力在陽光下運(yùn)行。堅(jiān)持反對腐敗,加強(qiáng)廉政建設(shè),從制度上改變權(quán)力過分集中而又得不到制約的狀況,做到干部清正、政府清廉、政治清明。
國內(nèi)外形勢的深刻變化,對我國開放型經(jīng)濟(jì)發(fā)展提出了新的更高要求。要堅(jiān)持對外開放的基本國策,實(shí)行更加積極主動(dòng)的開放戰(zhàn)略。堅(jiān)持把穩(wěn)定出口與擴(kuò)大進(jìn)口結(jié)合起來,推動(dòng)對外貿(mào)易從規(guī)模擴(kuò)張向質(zhì)量效益提高轉(zhuǎn)變、從成本和價(jià)格優(yōu)勢向綜合競爭優(yōu)勢轉(zhuǎn)變,促進(jìn)形成以技術(shù)、品牌、質(zhì)量、服務(wù)為核心的出口競爭新優(yōu)勢;堅(jiān)持把利用外資與對外投資結(jié)合起來,支持企業(yè)“走出去”,拓展經(jīng)濟(jì)發(fā)展的新空間;堅(jiān)持把深化沿海開放與擴(kuò)大內(nèi)陸和沿邊開放結(jié)合起來,加快形成各具特色、優(yōu)勢互補(bǔ)、分工協(xié)作、均衡協(xié)調(diào)的區(qū)域開放格局;堅(jiān)持把向發(fā)達(dá)國家開放與向發(fā)展中國家開放結(jié)合起來,擴(kuò)大和深化同各方利益匯合點(diǎn)。4.Deepening reform and opening up with greater political courage and vision Reform and opening up are the fundamental force that drives China's development and progress.We can continue to advance our cause only by adhering to reform and opening up.China has entered a crucial stage of reform.We must further emancipate our minds, comprehensively deepen reform of the economic structure, continue to actively yet prudently carry out reform of the political structure, deepen reform of the cultural administrative system, accelerate reform of the social system, improve the system for promoting ecological progress;and constantly deepen reforms.We need to improve the socialist market economy.We should unwaveringly consolidate and develop the public sector of the economy and encourage, and support and guide the development of the non-public sector, so as to foster a structural environment in which economic entities under different forms of ownership have equal access to factors of production in accordance with the law, compete on a level playing field and enjoy equal legal protection.We should deepen reform of state-owned enterprises and key industries.We should quicken reform of the fiscal and taxation systems, adjust relations between the central government and local governments concerning financial resources and powers, and improve the system of transfer payments.We should improve the public finance system, institute a system of local taxation, and establish a taxation system conducive to optimizing the economic structure and enhancing social fairness.We should deepen reform of the financial system and improve the modern financial system so that it supports development of the real economy.We should raise the competitiveness of the banking, securities and insurance industries, accelerate development of a multilevel capital market, and actively develop the bond market.We should steadily carry out reforms to make interest rates and the RMB exchange rate more market-based, expand cross-border use of the RMB and gradually achieve the RMB's convertibility under capital accounts.We should deepen reform of the investment and financing systems, carry out price reform and improve the pricing mechanism for resource products and the system of compensation for ecological damage.We should continue to actively yet steadily advance function-based reform of public institutions.The income distribution system is a basic system of vital importance for economic and social development, and an important cornerstone of the socialist market economy.We have formulated guidelines on deepening reform of the income distribution system, and we now need to promptly formulate specific policies, ensure that institutions are established and policies are implemented, resolve problems in income distribution, and narrow the income gap so that the fruits of development are more equitably shared by all the people.We need to advance development of socialist democracy and the socialist rule of law.We should ensure that the people occupy the principal position, make people's democracy more extensive, fuller in scope and sounder, ensure that the people enjoy extensive rights and freedoms prescribed by law, and promote people's well-rounded development and safeguard social fairness and justice.We should govern the country on the basis of the law, and fully respect the authority of the Constitution and laws.We should ensure that the powers of policy making, implementation and oversight both constrain each other and function in concert and that government bodies exercise their powers in accordance with statutory mandates and procedures.We should continue to transform government functions, separate government administration from the management of enterprises, state assets, public institutions and social organizations, and build a well-structured, clean, efficient and service-oriented government that has scientifically defined functions and that the people are satisfied with.We should improve the conduct of our work, maintain close ties with the people, advocate hard work and plain living, practice thrift, oppose extravagance and waste, and eliminate formalistic and bureaucratic practices.We should uphold democratic oversight, legal oversight and public opinion-based oversight and improve the system of checks and oversight over the exercise of power to ensure that the people oversee the exercise of power and that power is exercised in a transparent manner.We should unwaveringly combat corruption, strengthen political integrity, establish institutions to end the excessive concentration of power and lack of checks on power and ensure that officials are honest, government is clean and political affairs are handled with integrity.Profound changes in domestic and external environments place new and higher requirements on China in developing an open economy.We should adhere to the basic state policy of opening up and implement a more proactive opening up strategy.We should both keep exports stable and expand imports.We should raise the quality and returns of foreign trade rather than just increase its volume, and raise its overall competitive advantages instead of relying only on cost and price advantages.We should make China's exports more competitive in terms of technology, brand, quality and service.We should simultaneously use foreign investment in China and make Chinese investment overseas, and support Chinese enterprises in going global, to create new space for economic development.We should simultaneously deepen opening up in coastal areas and open inland and border areas wider so as to foster a balanced and coordinated pattern of opening up in which all regions have their own distinctive features, draw on each other's strengths, have a clear division of work, and cooperate with each other.We should continue to open up to both developed and developing countries and expand and deepen common interests with all other parties.
第五篇:max中的中英文對照
3Dmax中英文對照表
2010-08-11 13:36
ASSET BROWSER 資源瀏覽器
ASSIGN VERTEX COLORS 指定頂點(diǎn)顏色
BITMAP/PHOTOMETRIC PATH 位圖/光度學(xué)路徑 CAMERA MATCH 攝影機(jī)匹配
CAMERA TRACKER 攝影機(jī)跟蹤器
MOVIE 影片
MOTION TRACKERS 運(yùn)動(dòng)跟蹤器
MOVIE STEPPER 影片分節(jié)器
ERROR THRESHOLDS 錯(cuò)誤閾值
BATCH TRACK 批處理跟蹤
POSITION DATA 位置數(shù)據(jù)
MATCH MOVE 匹配移動(dòng)
MOVE SMOOTHING 移動(dòng)平滑
OBJECT PINNING 對象旋轉(zhuǎn)
CHANNEL INFO 通道信息
CLEAN MULTIMATERIAL 清理多維材質(zhì)
COLLAPSE 塌陷
COLOR CLIPBOARD 顏色剪貼板
COM/DCOM SERVER CONTROL COM/DCOM服務(wù)器控制 DYNAMICS 動(dòng)力學(xué)
TIMING & SIMULATION 計(jì)時(shí)和模擬
FILE LINK MANAGER 文件鏈接管理器
ATTACH 附加
FILES 文件
PRESETS 預(yù)設(shè)
FILE LINK SETTINGS 文件鏈接設(shè)置對話框 BASIC 基本選項(xiàng)卡
ADVANCED 高級選項(xiàng)卡
SPLINE RENDERING 樣條線渲染選項(xiàng)卡
FIX AMBIENT 固定環(huán)境光
FOLLOW /BANK 跟隨/傾斜
IFL MANAGER IFL管理器
INSTANCE DUPLICATE MAPS 實(shí)例化重復(fù)的貼圖 LEVEL OF DETAIL 細(xì)節(jié)級別
LIGHTING DATA EXPORT 照明數(shù)據(jù)導(dǎo)出器 LIGHTSCAPE MATERIALS LIGHTCAPE材質(zhì)
LINK INHERITANCE(SELECTED)鏈接繼承(選定)MATERIAL XML EXPORTER 材質(zhì)XML導(dǎo)出器 MAX FILE FINDER MAX文件查找程序
MAX SCRIPT MAX 腳本語言
MEASURE 測量
MOTION CAPTURE 運(yùn)動(dòng)捕捉
OBJECT DISPLAY CULLING 對象顯示消隱
PANORAMA EXPORTER 全景導(dǎo)出器
RENDER 渲染面板
VIEWER 查看器
POLYGON COUNTER 多邊形計(jì)數(shù)器
REACTOR 反應(yīng)堆動(dòng)力學(xué)
RESCALE WORLD UNITS 重縮放世界單位
RESET XFORM 重置變換
RESOURCE COLLECTOR 資源收集器
SHAPE CHECK 圖形檢查
SKIN UTILTIES 蒙皮工具
STROKES 筆畫
SURFACE APPROXIMATION 曲面近似
UVW REMOVE UVW移除
VISUAL MAX SCRIPT 可視化腳本語言
MATERIAL EDITOR 材質(zhì)編輯器
ANISOTROPIC 各向異性
METAL 金屬
MULTI-LAYER 多層
TRANSLUCENT SHADER 半透明明暗器
ADVANCED LIGHTING OVERRIDE 高級照明覆蓋材質(zhì)
ARCHITECTURAL 建筑材質(zhì)
TEMPLATES 模板
PHYSICAL QUALITIES 物理特性
SPECIAL EFFECTS 特殊效果
ADVANCED LIGHTING OVERRIDE 高級照明覆蓋
CUTOUT 裁切(貼圖)
BLEND 混合材質(zhì)
COMPOSITE 合成材質(zhì)
DOUBLE SIDED 雙面材質(zhì)
MORPHER 變形器材質(zhì)
MULTI/SUB-OBJECT 多維/子對象材質(zhì)
SHELLAC 蟲漆材質(zhì)
TOP/BOTTOM 頂/底材質(zhì)
IND`N PAINT 卡通材質(zhì)
LIGHTSCAPE MTL LIGHTSCAPE材質(zhì)
MATTE/SHADOW 無光/投影材質(zhì)
RAYTRACE 光線跟蹤材質(zhì)
RAYTRACE BASIC PARAMETERS 光線跟蹤基本參數(shù)
EXTENDED PARAMETERS 擴(kuò)展參數(shù)
RAYTRACER CONTROLS 光線跟蹤器控制
SUPER SAMPLING 超級采樣
MAPS 貼圖
DYNAMICS PROPERTIES 動(dòng)力學(xué)屬性
RAYTRACER GLOBAL PARAMETERS 全局光線跟蹤設(shè)置
INCLUDE/EXCLUDE 包含/排除
SHELL MATERIAL 殼材質(zhì)
STANDARD 標(biāo)準(zhǔn)材質(zhì)
SHADER BASIC PARAMETERS 明暗器基本參數(shù)
BASIC PARAMETERS 基本參數(shù)
EXTENDED PARAMETERS 擴(kuò)展參數(shù)
SUPER SAMPLING 超級采樣
MAPS 貼圖
DYNAMICS PROPERTIES 動(dòng)力學(xué)屬性
DIRECT3D VIEWPORT SHADERS DIRECT3D視口明暗器
XREF MATERIAL 外部參照材質(zhì)
二維貼圖
COORDINATES 貼圖坐標(biāo)參數(shù)
NOISE 噪波參數(shù)
BITMAP 位圖貼圖
TILES平鋪貼圖
CHECKER 棋盤格貼圖
COMBUSTION 貼圖
GRADIENT 漸變貼圖
GRADIENT RAMP 漸變坡度貼圖
SWIRL 漩渦貼圖
三維貼圖
COORDINATES 貼圖坐標(biāo)
CELLULAR 細(xì)胞貼圖
DENT 凹痕貼圖
FALLOFF 衰減貼圖
MARBLE 大理石貼圖
NOISE 噪波貼圖
PARTICLE AGE 粒子年齡
PARTICLE MBLUR 粒子運(yùn)動(dòng)模糊貼圖
PERLIN MARBLE PERLIN大理石貼圖
PLANET 行星貼圖
SMOKE 煙霧貼圖
SPECKLE 斑點(diǎn)貼圖
SPLAT 潑濺貼圖
STUCCO 灰漲貼圖
WAVES 波浪貼圖
WOOD 木材貼圖
COMPOSITE 合成貼圖
MASK 遮罩貼圖
MIX 混合貼圖
RGB MULTIPLY RGB相乘貼圖
COLOR MODIFIER 顏色修改貼圖
OUTPUT 輸出
RGB TINT RGB染色
VERTEX COLOR 頂點(diǎn)顏色
OTHER 其它
CAMERA MAP PER PIXEL 每像素?cái)z影機(jī)貼圖
NORMAL BUMP 法線凹凸
FLAT MIRROR 鏡面反射貼圖
RAYTRACE 光線跟蹤貼圖
REFLECT/REFRACT 反射/折射貼圖
THIN WALL REFRACTION 薄壁折射貼圖
MATERIAL/MAP BROWSER 材質(zhì)/貼圖瀏覽器
環(huán)境與效果
BACKGROUND 背景
GLOBAL LIGHTIG 全局光照
EXPOSURE CONTROL 曝光控制
AUTOMATIC EXPOSURE COTROL 自動(dòng)曝光控制
LINEAR EXPOSURE CONTROL 線性曝光控制
PSEUDO COLOR EXPOSURE CONTROL 偽彩色曝光控制
ATMOSPHERE 大氣
FIER EFFECT 火效果
FOG 霧
VOLUME FOG 體積霧
VOLUME LIGHT 體積光
LENS EFFECTS 鏡頭效果
GLOW 光暈
RING 光環(huán)
RAY 射線
AUTO SECONDARY 自動(dòng)二級光斑
MANUAL SECONDARY 手動(dòng)二級光斑
STAR 星形
STREAK 條紋
BLUR 模糊
BRIGHTNELL AND CONTRAST 亮度和對比度
COLOR BALANCE 色彩平衡
FILE OUTPUT 文件輸出
FILE GRAIN 膠片顆粒
MOTION BLUR 運(yùn)動(dòng)模糊
DEPTH OF FIELD 景深
HAIR AND FUR RENDER EFFECT 毛發(fā)渲染效果
渲染
RENDER SHORTCUTS 渲染快捷方式工具欄
RENDER SCENE 渲染場景對話框
COMMON PARAMETERS 公用參數(shù)
E-MAIL NOTIFICATIONS 電子郵件通知
SCRIPTS 腳本
ASSIGN RENDERER 指定渲染器
DEFAULT SCANLINE RENDERER 默認(rèn)掃描線渲染器
VUE FILE RENDERER VUE文件渲染器
RENDER ELEMENTS 渲染元素
RENDER FRAME WINDOW 渲染幀窗口
RENDER OUTPUT 渲染文件輸出面板
COMMON PARAMETERS 公用參數(shù)
DEFAULT SCANLINE RENDER 默認(rèn)掃描線渲染器
PRINT SIZE WIZARD打印大小向?qū)?/p>
PREVIEW RENDERINGS 預(yù)覽渲染
RENDER TO TEXTURE 渲染到紋理
GENERAL SETTINGS 常規(guī)設(shè)置
OBJECT TO BAKE 烘焙對象
OUTPUT 輸出
BAKED MATERIAL 烘焙材質(zhì)
AUTOMATIC MAPPING 自動(dòng)貼圖
ACTIVE SHADE 動(dòng)態(tài)著色渲染
ACTIVE SHADE FLOATER 動(dòng)態(tài)著色浮動(dòng)窗口
ACTIVE SHADE VIEWPORT 動(dòng)態(tài)著色視口
RAYTRACE 光線跟蹤
RAYTRACER SETTINGS 光線跟蹤器設(shè)置
RAYTRACE GLOBAL EXCLUDE/INCLUDE 光線跟蹤排除/包含
ADVANCED LIGHTING 高級照明
LIGHT TRACER 光跟蹤器
RADIOSITY 光能傳遞
ADVANCED LIGHTIG OVERRIDE 高級照明覆蓋
NETWORK RENDERING 網(wǎng)格渲染
NETWORK JOB ASSIGNMENT 網(wǎng)絡(luò)作業(yè)分配
BACKBURNER MANAGER 網(wǎng)絡(luò)渲染管理器
BACKBURNER MANAGER GENERAL PROPERTIESBACKBURNER管理器常規(guī)屬性 BACKBURNER MANAGER LOGGING PROPERTIESBACKBURNER管理器日志屬性 BACKBURNER SERVER 網(wǎng)絡(luò)渲染服務(wù)器
QUEUE MONITOR 隊(duì)列監(jiān)視器
COMMAND RENDER 命令行渲染
SAMPLING QUALITY 采樣質(zhì)量
RENDERING ALGORITHMS 渲染算法
CAMERA EFFECTS 攝影機(jī)效果
SHADOWS & DISPLACEMENT 陰影與置換
INDIRECT ILLUMINATION 間接照明面板
CAUSTICS AND GLOBAL ILLUMINATION 焦散和全局照明(GI)
FINAL GATHER 最終聚集
PROCESSING 處理面板
TRANSLATOR OPTIONS 轉(zhuǎn)換器選項(xiàng)
DIAGNOSTICS 診斷
DISTRIBUTED BUCKET RENDERING 分布式塊狀渲染
MATERIAL SHADERS 材質(zhì)明暗器卷展欄
ADVANCED SHADERS 高級明暗器卷展欄
DGS MATERIAL(PHYSICS_PHEN DGS材質(zhì)
DGS MATERIAL(PHYSICS_PHEN)PARAMETERS DGS材質(zhì)參數(shù)卷展欄 SUBSURFACE SCATTERING(SSS)曲面散色材質(zhì)
MENTAL RAY CONNECTIONMENTAL RAY材質(zhì)卷展欄 3D DISPLACEMENT SHADER 3D置換明暗器
BUMP SHADER 凹凸明暗器
DIELECTRIC MATERIAL SHADER 絕緣材質(zhì)明暗器
ENVIRONMENT SHADER 環(huán)境明暗器
MATERIAL TO SHADER 材質(zhì)轉(zhuǎn)換為明暗器
SHADER LIST SHADER列表
UV GENERATOR SHADER UV發(fā)生器明暗器
UV COORDINATE SHADER UV坐標(biāo)明暗器
XYZ GENERATOR SHADER XYZ發(fā)生器明暗器
XYZ COORDINATE SHADER XYZ坐標(biāo)明暗器