第一篇：FDA可在年度报告中提出的变更指南 中英文对照范文
201006 FDA行业指南 可在年报中报告的CMC已批准生产变更草案（中英文）2013-01-22 16:04:09| 分类： FDA|字号 订阅
Guidance for Industry
行业指南
CMC Postapproval Manufacturing Changes Reportable in Annual Reports
可在年报中报告的CMC已批准生产变更
DRAFT GUIDANCE
指南草案
This guidance document is being distributed for comment purposes
only.本指南文件仅供征求意见。
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be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.Submit comments to the Division of Dockets Management(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.1061, Rockville, MD 20852.All comments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.关于本草案的问题请联系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
行业指南
CMC Postapproval Manufacturing Changes Reportable in Annual Reports
可在年报中报告的CMC已批准生产变更 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.xiexiebang.complianceRegulatoryInformation/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.介绍............................................................................................................1 II.BACKGROUND.背景..............................................................................................................1 III.DISCUSSION..讨论..................................................................................................................2 IV.CONTENTS OF ANNUAL REPORT NOTIFICATION.年报通知的内容.........................4 APPENDIX A: CMC POSTAPROVAL MANUFACTURING CHANGES REPORTABLE IN ANNUAL REPORTS......................................................附件A：可在年报中报告的CMC已批准生产变更
Guidance for Industry[1] 行业指南
CMC Postapproval Manufacturing Changes Reportable in Annual Reports
可在年报中报告的CMC已批准生产变更
This draft guidance, when finalized, will represent the Food and Drug Administration’s(FDA’s)current thinking on this topic.It does not create or confer any rights for or on any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，如果最终定稿，代表的是FDA目前对这一专题的态度。它并未建立或赋予任何个人任何权利，并不与FDA或公众有任何绑定。你可以使用任何一种替代方法，只要所用的方法满足成文的法规要求。如果你想要讨论一个替代方法，请与FDA负责实施本指南的相关人员联系。如果你无法无法识别要联系的人，可以拨打本指南首页所列的相应的电话号。
I.INTRODUCTION 介绍 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] 本指南给NDA和ANDA持有人提供建议，说明哪些变更可以在年报中进行报告。指南专门针对的是化学、生产和控制（CMC）批准后生产变更，哪些可能对产品质量产生潜在不良影响很小，因此可以在年度报告中进行报告。
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已批准生产变更，我们认为一般来说对产品质量（与产品安全性或有效性相关的属性，如产品鉴别、剂量、质量、纯度和效价）影响较低，但之前要求在生产增补中提交的变更。
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，并未设立法律强制责任。它只是描述了当局目前对某一主题的想法，如果未引用特定的法律法规要求的话，应仅作为推荐。“应当should”一词在指南中表示建议或推荐的做法，并非强制。
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.对于已根据相关的法规要求—包括联邦食品药品和化妆品法案（21 U.S.C.356a）第506A条（该条款经由食品和药品现代化法案和21CFR第314.70条增加）获得批准的申请，申请人必须将相关变更通知FDA。法案的第506A条说明了对已批准的申请生产变更报告要求，和对药品的销售变更报告要求。根据21CFR314.70，所有超出已批准的NDA和ANDA中已有变更范围的预批准CMC变更均属于三个报告类别之一：重大、中等、轻微。
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] 如果变更被作为是重大变更，则申请人必须提交变更至FDA，并在收到FDA批准后才能将变更后工艺生产的产品用于销售。如果变更被作为是中等，申请人必须在产品销售前30天提交变更申请，或在某些情况下，在销售同时提交变更申请。如果变更被作为是轻微的，则申请人可以直接进行变更，但必须在变更当年的年报中通知FDA。对于任何变更，申请人均必须评价变更对产品安全性和有效性的影响，通过适当的研究证明该变更是否需要提交变更申请。更多与NDA和ANDA报告分类相关的背景资料，请参见FDA指南“已批准的NDA和ANDA的变更”（2004年4月）（注释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.在我们2004年9月最终报告“21世纪药品CGMP—基于风险的方法”（药品质量创新）中，FDA申明继续进行质量管理规范倡议，促进当局更有效利用我们有限的法规资源。我们将建立一个合作的，基于风险的方法对药品生产进行管理。作为该方法的一部分，FDA决定提供更有效的公共安全保护，我们的CMC法规审核将基于对产品风险的理解，以及如何更好地管理这种风险。
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，申请人还需要符合其它与申报相关的法律法规，包括在21CFR（美国联邦法规）第210和211中关于制剂CGMP的法规。
III.DISCUSSION 讨论
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.在过去几年中，对NDA和ANDA的CMC生产变更申请数目持续增长。与FDA的“药品质量倡议”和我们对CMC基于风险的审核方法相关连，我们对已提交的CMC批准后生产变更进行了评价，并认为其中许多变更对产品质量的风险极小，不需要提交变更批准。
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.基于最近的评价，我们列出了一个清单（见附件A），向公司建议，对于一些可以认为对药品的鉴别、剂量、质量、纯度或效价只有非常小的潜在负面影响的已批准的NDA和ANDA生产变更，可以归类为年报变更（例如实施后通知类型），而不需要提交增补。根据生产变更的类型分类的变更，以及对变更分类的增加和修订已在指南“已批准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，如果你正准备根据“已批准NDA或ANDA”中CMC变更建议提交增补申请，你需要同时参考基于风险的建议清单，该清单是本指南附件A，以决定某个具体的变更现在是否可以在年报中报告。另外，本指南中的建议可以帮助澄清什么时候需要提交一个增补，什么时候变更可以包括在年报中。
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] 我们希望NDA和ANDA持有人对具体的计划中的变更进行评价，根据其具体的环境来决定提议的变更是否对药品的鉴别、剂量、质量、纯度或效价只有非常小的潜在负面影响。基于该分析，NDA或ANDA持有人可以决定在附件A中所述的变更是否更适合提交一个增补，而不是在年报中报告。在此，我们认为本指南仅是提供一些建议，说明一些变更可能可以在年报中报告，而不是根据21CFR 314.70(a)(3)强制要求这些变更必须在年报中报告。
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] 申请人应记住，不管已批准的生产变更如何分类，这些变更都需要符合21CFR 210和211中CGMP对制剂法规的要求。同时，申请人还要注意FDA对活性原料药生产的建议已包括在行业指南“Q7A 原料药GMP”中。CGMP对制剂的法规包括对本指南中所述的变更类型的特定要求，不管变更类型如何，所有变更均需要符合CGMP法规要求。CGMP要求包括了需要确认设备是否符合其用途，需要使用验证过的检验方法，生产工艺应处于受控状态，需要维护适当、经过质量部分审核和批准的书面程序。
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).如有关于某个变更是否需要提交增补还是可以在年报中报告的问题，建议联系我们ONDQA的CDER审核部门、OGD或OPS-NDMS.IV.CONTENTS OF ANNUAL REPORT NOTIFICATION 年度通知的内容 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.为使用年报中通知的变更符合21CFR 314.81(b)(2)(iv)(b)和314.70(d)(3)的要求，申请人必须在年报中包括关于CMC变更的完整描述，说明申请人认为该变更不需要根据、314.70(b)和(c)部分提交增补。该描述应包括（1）变更清单（以实施日期为序）（2）用以评价变更影响的研究和检测数据总结，包括验证方案、标准操作程序和方针的交叉引用，（3）所有受影响产品的清单。申请人应在年报中对每个变更进行详细描述，使得审核人员可以快速决定该变更采用年报报告是否合适。另外，申请人应在年报的概述部分包括一个变更清单（注释9）。如果提交的变更不应该在年报中进行报告，申请人将被告知正确的分类是什么，并会被要求补充资料。
APPENDIX A: CMC POSTAPROVAL MANUFACTURING CHANGES REPORTABLE IN ANNUAL REPORTS
附件A：可在年报中报告的CMC生产类变更 Components and Composition 组件和成份 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.去除或减少之前用于补偿生产损耗而比处方多出来的部分。注意本点不适用于在存贮过程中会损失的效价。
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.立即放行固体制剂包衣配方及数量变更，而该变更后的包衣材料和数据已在另一产品中得到批准，且西方变更不会改变药品的放行。
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.活性成分增加新供应商，该活性成分对制剂产品性能影响极小，且保持可接受标准不变。Manufacturing Sites 生产场所
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.对已批准的生产场所进行修改，不影响产品生产区域或无菌区域，不影响产品质量或标准。
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.增加隔断，以保护充填或合成区域不受常规人流干扰，并经过已有程序确认和验证
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: 在已批准的多功能区域生产另一种药品（包括临床或研发产品），如果满足以下条件 2.3.1 specific identity tests exist to differentiate between all products manufactured at the facility;and 有专属性鉴别试验可以区别在该场所生产的任何产品，且
2.3.2 a change-over procedure between manufacturing processes is established;and 建立了更换产品程序，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.所有产品风险水平不会增加。风险水平增加可能包括，但不仅限于，高毒性或高效价产品，高免疫性或致敏性产品（例如，青霉素），会加快另一产品降解的产品（例如，酶），引入新的或外来风险的产品，或成人用药增加到幼儿用药生产线上。Manufacturing Process 生产工艺
3.1 Process changes including any of the following: 包括以下任一内容的工艺变更
3.1.1 Addition of a sieving step(s)for aggregate removal if it occurs under nonaseptic conditions.在非无菌条件下增加过筛步骤，以除去团料
3.1.2 Changes in mixing times for immediate-release solid oral dosage forms and for solution products.立即放行的固体口服制剂和液体产品混合时间变更
3.1.3 Changes in drying times for immediate-release solid oral dosage forms.立即放行的口服固体制剂干燥时间变更
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.在所有批准均符合已批准的过程控制限度，下一步关键操作参数均保持不受影响的前提下，对还需要进行下一步生产工艺的收集液体量或子批次批量进行变更。
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).更换设备，设备设计和操作原理相同，不影响工艺操作方法或过程控制限度，无菌工艺设备除外（例如新的充填线、新的冻干器）
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.原料药和制剂生产中增加一套同样的工艺设备或单元，对过程控制限度或产品质量标准不进行变更。
3.5 Addition of, deletion of, or change in a reprocessing protocol for refiltrations to control bioburden because of integrity test failures.由于整体检测失败，增加、删除或变更控制微生物的过滤工艺
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).不改变工艺无改进意义情况下减少敞开操作步骤（例如，采用无菌连接设备替换防火保护操作程序）
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.在验证过的参数范围内，对过滤工艺参数进行变更（例如流速、压力、时间或容量，但不变更过滤材质或孔径），但不对新的参数进行新的验证。
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.无菌原料药的包装/容器制备灭菌用具，从验证过的灭菌器（环氧乙烷EtO自动灭菌器）改为相同设计相同操作原理的设备，且新的灭菌器参数经过验证，在原验证过的参数下可以操作的。这里不包括验证参数变更的情况。Specifications 质量标准
4.1 Addition of a specification for existing excipients.增加已有辅料的质量标准
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: 变更原料药或药品的质量标准，使符合官方药典，符合下列情形时可在年报中报告
4.2.1 A change to tighten an existing acceptance criterion;or 该变更加严已有的可接受标准，或
4.2.2 Other changes, except for changes to assays, impurities, product-related substances, or biological activities in approved NDAs and ANDAs.其它变更，变更不涉及已批准的NDA或ANDA的含量、杂质、产品有关物质或生物活性
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).已批准的检验方法变更，修订后的检验方法保持相同的方法，具有等效性或更好保证原料药或药品所申明的鉴别、剂量、质量、纯度或效价方面的特性，或其可接受标准保持不变（例如，改变HPLC方法的流速或样品溶液配制）
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).采用一个有专属性的鉴别取代一个非专属性的鉴别，导致可接受标准变更（例如，用肽图替代SDS-PAGE，见注11）4.5 Addition of an in-process test.增加中控检验
4.6 Replacement of blend uniformity and in-process homogeneity tests with other appropriate testing that assures adequacy of mix.采用另一适当的，可以保证混合充分性的检测，替代现有混合均一性和中控均一性检测。
4.7 Revision of tablet hardness if there is no significant change in the dissolution profile.不显著改变溶出度结果的情况下，改变片剂硬度
4.8 Elimination of an in-process disintegration test where a dissolution test is required for release.放行包括溶出度检测的情况下，取消中控的崩解测试
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.申请者有过程控制证明产品均一性时，删除包括在注册资料中日常均一性检测
4.10 Addition of a test for packaging material to provide increased assurance of quality.对包装材料增加检测，以提高质量保证
4.11 Tightening of an existing acceptance criterion.加严格已有的可接受标准 Container/Closure System 密封/包装系统
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.对无菌原料药用于存贮的密封/包装系统进行变更，提出的变更不增加浸出物风险，没有新增可萃取物质，具有相等的保护特性。
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.采用一个合同生产组织（CMO）清洗药品瓶塞，已提供申请人执照，CMO的清洁过程已经过验证，CMO的工厂已经过申请人（或由申请人指定的另一方）审计，确认符合CGMP要求。
5.3 For solid oral dosage forms: 对于固体口服制剂
5.3.1 Elimination of bottle dunnage.去除瓶上手提装置 5.3.2 Change in type of desiccant to another equivalent desiccant that was previously used in another approved product.将干燥剂改为在另一已批准的产品中使用的另一同等能力的干燥剂
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.对于非口服药品，在不改变玻璃瓶种类和涂层及尺寸的情况下变更供应商。
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.对密封盖（套金属和盖/密封），如果标识方式无变化，颜色、整体密封包装形式经验证过的检验方法证明无变化。Miscellaneous Changes 其它变更
6.1 Extension of expiry based on real-time stability data from pilot scale batches following an approved stability protocol.根据已批准的稳定性试验方案，基于中试规模进行的实时稳定性试验数据延长有效期
6.2 Reduction of expiration dating for a drug product for reasons other than stability failures.由于非稳定性失败的原因缩短药品有效期
6.3 If a dissolution test is performed, elimination of a nonstability indicating test for identity or hardness from an approved stability protocol.在进行溶出度试验前提下，将鉴别或硬度非稳定性指示试验从已批准的稳定性试验方案中删除
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”
在对一个与之前已批准的组合增补的范围和要求完全一致的申请进行变更时，同一申请人可以增加类似的药品（见MAPP 5015.6“对需多部门审核的多个NDA或ANDA的相同增补的审核”）
[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.xiexiebang.complianceRegulatoryInformation/Guidances/default.htm.[6] Note that the guidance, Changes to an Approved NDA or ANDA, will be revised to reflect these recommendations.注意该指南“已批准的NDA或ANDA的变更”将进行修订以反映这些建议。[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.根据21CFR 314.70(a)(3)，申请人应根据较少繁杂的法规或指南进行变更，但在本指南中，我们要求申请人进行判定，哪一种变更需要进行预批准增补。
[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 参见活性成分指南，可以以下网站找到www.accessdata.fda.gov/scripts/cder/iig/index.cfm.[11] SDS-PAGE stands for sodium dodecyl sulphate polyacrylamide gel electrophoresis.
第二篇：外商投资企业注册登记指南(中英文对照)（本站推荐）
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;全体投资人签署的《外商投资企业名称预先核准申请书》；
2.Photocopies of qualification certificates of all investors;全体投资人的资格证明复印件； 3.Other relevant documents and certificates;其他有关文件、证件；
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 拟任法定代表人签署的《外商投资的公司设立登记申请书》
2、The approval document issued by the approval authority(one duplicate of official reply and approval certificate);审批机关的批准文件（批复和批准证书副本1）
3、Articles of association公司章程
4、The notification of name pre-approval 《名称预先核准通知书》
5、Proof of subject qualification or proof of identification as a natural person for investors 投资者的主体资格证明或自然人身份证明
6、Photocopies of documents of appointment and proof of identification for directors, supervisors and managers董事、监事和经理的任职文件及身份证明复印件
7、Photocopies of documents of appointment and proof of identification for legal representative法定代表人任职文件和身份证明复印件
8、Investment verification certificates issued by a legally established investment verification authority依法设立的验资机构出具的验资证明
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.股东首次出资是非货币财产的，提交已办理财产权转移手续的证明文件
10、Certificate of company domicile公司住所证明
11、The minutes of the inaugural assembly;创立大会的会议记录
12、Pre-approval document or certificate;前置审批文件或证件
13、Letter of authorization for service of legal documents 法律文件送达授权委托书
14、Other relevant documents and certificates;其它有关文件
For registration of establishment of a Foreign-Invested enterprise(non-company)
1、“The application from signed by the pending legal representative”;拟任法定代表人签署的《（非公司）外商投资企业设立登记申请书》
2、The approval document issued by the approval authority(one duplicate of official reply and approval certificate);审批机关的批准文件（批复和批准证书副本1）
3、Contract and articles of association;合同、章程
4、“The notification of name pre-approval” 名称预先核准通知书
5、Investor's legal business certificate and credit certificate;投资者的合法开业证明和资信证明
6、Photocopies of documents of appointment and proof of identification for legal representative and members of Joint management committee法定代表人、联合管理委员会委员任职文件原件及身份证明复印件
7、The certificate of using the new domicile;住所使用证明
8、Investment verification certificates issued by a legally established investment verification authority依法设立的验资机构出具的验资证明
9、Pre-approval document or certificate;前置审批文件或证件
10、Other relevant documents and certificates;其它有关文件
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 清算组负责人签署的《外商投资的公司注销登记申请书》
2、The approval document issued by the original approval authority agreeing the cancellation;原审批机关同意注销的批准文件
3、Resolution or decision made in accordance with laws依法作出的决议或者决定
4、Liquidation report that has been recorded and confirmed in accordance with laws经依法备案、确认的清算报告
5、Certificate for registration of cancellation issued by taxation and customs authorities税务和海关部门出具的完税证明
6、Certificate for registration of cancellation of branches分公司的注销登记证明
7、The original and the duplicate business license营业执照正、副本
8、Other relevant documents and certificates;其它有关文件
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 《外商投资企业注销登记申请书》
2、原审批机关同意注销的批准文件
3、依法作出的决议或决定
4、清理债权债务完结的报告或者清算组织负责清理债权债务的文件
5、税务和海关出具的完税证明
6、分支（办事）机构已注销的证明
7、营业执照正、副本和公章
8、其它有关文件
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、《外商投资企业变更（备案）登记申请书》
2、依法作出的决议或决定
3、营业执照副本复印件
4、名称变更核准通知书
5、公司法定代表人签署的公司章程修正案或修改后的公司章程
6、其他有关文件
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、《外商投资企业变更（备案）登记申请书》
2、依法作出的决议或决定
3、公司法定代表人签署的公司章程修正案或修改后的公司章程
4、住所使用证明
5、营业执照副本复印件
6、其他有关文件
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、《外商投资企业变更（备案）登记申请书》
2、依法作出的决议或决定
3、原法定代表人的免职文件和新任法定代表人的任职文件
4、新任法定代表人登记表
5、营业执照副本复印件
6、审批机关的批准文件
7、其它有关文件
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、《外商投资企业变更（备案）登记申请书》
2、审批机关的批准文件（批复和批准证书副本1）
3、依法作出的决议或决定
4、合同、章程的修改协议
5、公司法定代表人签署的公司章程修正案或修改后的公司章程
6、依法设立的验资机构出具的验资证明
7、刊登减资公告的报纸报样及债务清偿报告或债务担保证明
8、营业执照副本复印件
9、其它有关文件
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、《外商投资企业变更（备案）登记申请书》
2、依法设立的验资机构出具的验资证明
3、营业执照副本复印件
4、其它有关文件
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、公司法定代表人签署的《外商投资的公司变更（备案）登记申请书》
2、审批机关的批准文件(批复和批准证书副本1）
3、依法作出的决议或决定
4、公司法定代表人签署的公司章程修正案或修改后的公司章程
5、营业执照副本复印件
6、其它有关文件
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、《外商投资企业变更（备案）登记申请书》
2、审批机关的批准文件（批复和批准证书副本1）
3、依法作出的决议或决定
4、合同、章程的修改协议
5、公司法定代表人签署的公司章程修正案或修改后的公司章程
6、营业执照副本复印件
7、其它有关文件
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、《外商投资企业变更（备案）登记申请书》
2、审批机关的批准文件（批复和批准证书副本1）
3、依法作出的决议或决定
4、合同、章程的修改协议
5、公司法定代表人签署的公司章程修正案或修改后的公司章程
6、营业执照副本复印件
7、前置审批文件或证件
8、其他有关文件
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、外商投资企业变更（备案）登记申请书
2、审批机关的批准文件（批复和批准证书副本1）
3、依法作出的决议或决定
4、合同、章程的修改协议
5、公司法定代表人签署的公司章程修正案或修改后的公司章程
6、股权转让协议
7、依法经其他投资方同意转让的声明
8、股权受让方的主体资格证明
9、股权受让方的资信证明
10、法律文件送达授权委托书
11、营业执照副本复印件
12、其它有关文件
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、《外商投资企业变更（备案）登记申请书》
2、审批机关的批准文件（批复和批准证书副本1）
3、投资者名称变更的证明文件
4、公司法定代表人签署的公司章程修正案或修改后的公司章程
5、营业执照副本复印件
6、其它有关文件
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、公司法定代表人签署的《外商投资企业变更（备案）登记申请书》
2、审批机关的批准文件（批复和批准证书副本1）
3、依法作出的决议或决定
4、公司法定代表人签署的公司章程修正案或修改后的公司章程
5、营业执照副本复印件
6、其它有关文件
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、《外商投资企业变更（备案）登记申请书》
2、依法作出的决议
3、审批机关的批准文件
4、营业执照复印件
5、其它有关文件
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、《外商投资企业变更（备案）登记申请书》
2、依法作出的决议或决定
3、审批机关的批准文件
4、分支（办事）机构登记机关出具的注销证明
5、营业执照副本复印件
6、其它有关文件、证件
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、《外商投资企业变更（备案）登记申请书》
2、原董事、监事、经理的免职文件和新任董事、监事、经理的任职文件及身份证明复印件
3、原联合管理委员会委员的免职文件和新任联合管理委员会委员的任职文件及身份证明复印件
4、《董事、监事、经理/联合管理委员会委员情况表》
5、营业执照副本复印件
6、其它有关文件
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;股权质押：
a.《外商投资企业变更（备案）登记申请书》
b.审批机关批准文件
c.依法做出的决议或决定
d.依法经其他投资方同意的质押合同
e.营业执照副本复印件
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.《外商投资企业变更（备案）登记申请书》
b.分公司营业执照副本的复印件
c.公司营业执照副本的复印件
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 清算组成员清算组负责人：
a.公司清算组负责人签署的《外商投资企业变更（备案）登记申请书》
b.依法做出的决议或决定
c.营业执照副本复印件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;不涉及登记事项的章程修改：
a.《外商投资企业变更（备案）登记申请书》
b.审批机关的批准文件
c.公司法定代表人签署的公司章程修正案或修改后的公司章程
d.营业执照副本复印件
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;境外股东、发起人法律文件送达接受人：
a.《外商投资企业变更（备案）登记申请书》
b.《法律文件送达授权委托书》
c.被授权人的主体资格证明复印件
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
工商登记联络员：
a.《外商投资企业变更（备案）登记申请书》
b.工商登记联络员基本情况
第三篇：FDA发布可以通过年报报告的批准后生产变更指南
CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports
可以通过年报报告的批准后生产变更
源网址：http://www.xiexiebang.complianceRegulatoryInformation/Guidances/UCM217043.pdf
日期：2014.3
类型：生效
摘要：本指南的目的旨在为NDA和ANDA申请者提供一些建议，关于哪些类型的变更可以通过年报来报告，需要注意的是，本指南中所提到的关于化学，生产和控制(CMC)的批准后变更是指已经明确了对产品质量本身几乎不会产生不良反应的变更，因此，可以通过年报报告。
内容简报：该指南的主要内容如下：
申请者需根据法规要求将产品批准后的变更告知FDA。根据21CFR314.70，对于NDA和ANDA，所有的CMC批准后的变更分为三类：大变更(major)，中等变更(moderate)和小变更（minor）。对于大变更，NDA和ANDA申请者必须向FDA递交补充申请（也称为PAS）并要求在得到批准后方能实施变更。若变更被认为是中等变更，申请者必须在产品分销前至少30天提交补充申请（CBE-30 supplement），在某些情况下可以在分销时递交补充申请（CBE-0 supplement）。如果某个变更认为是小变更，申请者可以自行执行此变更，但需要通过年报告知FDA。对于任何一种变更，申请都需要评估其对于产品质量的影响。
近年来NDA和ANDA递交的CMC生产补充申请越来越多。FDA在评估了很多批准后变更申请后认为许多报告的变更对产品本身的质量影响的风险很低，认为这些变更不需要以批准后变更（PAS）的方式递交。
基于风险评估的基础，FDA提供了一个清单（见附件A），其中列举了一些对于产品质量产生不良反应的风险较低的例子，对于此类变更不需要递交补充申请（PAS），可以执行后在下一年的年报中体现。
列在附件A中的变更是根据生产变更的种类来分类的。这些变更是对SUPAC指南或其他相关指南中提到的需在年报中报告的变更的修订或补充。因此在基于此前的指南来递交补充申请前有必要参考一下本指南附件A中提到建议。
我们希望NDA或者ANDA申请者在提交申请前能以书面的形式来评估变更对产品质量是否存在不良反应。若评估结果表明此变更对产品质量影响很小，那么变更可以在下一年的年报中体现。当然，NDA或者ANDA申请者也可以根据产品实际的情况来决定，附件A或B中列举的变更可能通过补充申请（PAS）的途径来报告更合适。在这种情况下，应该根据风险评估的结果和21CFR 314.70的要求来报告变更给当药政当局。因此，本指南的目的是对能在年报中报告的变更提出一些建议，而非强制此类变更必须按照21CFR 314.70以年报形式报告。
对于在本指南中没有提到的变更，或者其他多个同时执行的相关的变更，申请者可以参考其他CDER指南（见第四部分）或附件B来决定合适的报告种类（e.g.PAS, CBE-30, CBE-0或者年报）。
需要注意的是，对于活性成分的生产请参考Q7A。成品的CGMP法规中包含的一些与变更种类有关的特定要求都在本指南中有提到。无论是以哪种形式来报告的变更都必须要符合CGMP。CGMP法规包括建立并符合相应的书面文件，并且该文件需要经过质量控制部分的审核和批准，设备是合格可用的，方法需要经过验证，商业生产工艺是建立在科学基础上，确保生产工艺过程可控（根据变更的情况可能需要进行额外的工艺验证和稳定性研究。）。
对于以年报形式报告的变更,申请者需对CMC变更进行详细的阐述来表明此变更不需要以补充申请（PAS）的形式递交，阐述的内容包括：
以清单的形式列举每个变更和相应的执行日期，以及
评估产品质量影响的研究数据汇总表，如变更控制的交叉索引清单和变更验证方案，以及用于评估变更影响的SOP 还应包括：
在变更中受到影响的一个或多个产品名（不同规格和产品）或者， 如果变更影响到多个产品，索引到任何之前已经批准的“grouped supplements”(指变更影响到多个产品，其中的某些产品已经递交过变更)
批记录，SOP和用于评估每种变更的研究数据以及检测都应该存档以便官方查看（如现场检查时）。申请者应该在年报中尽可能详细的描述每种变更，这样有利于官方判断变更的分类是否正确。如果递交的变更不适合在年报中报告，申请者将会被通知以正确的分类来递交或者补充额外信息。附件A 通过年报报告的对产品质量产生不良反应风险较小的CMC变更实例
1.组成和成分
除去或减少制剂产品生产中处方中的过量投料，该过量本来的目的是为了补偿生产过程中的损失。
固体速释制剂的包衣成分的改变，前提是该包衣材料的用量已经被其他相似的已获批产品使用过，并且该变更不会改变药物的释放或者质量标准（如检测项，分析方法或可接受标准），或者稳定性。
非活性成分供应商变更（如，从一个DMF holder更换成另一个DMF holder，或者换成新的合格的供应商），这种变更的前提是非活性物质的质量标准不发生改变。
2.生产地址
已经被批准的无菌制剂厂进行微小结构改造，前提是该变更不会影响产品生产区或无菌保障，也不会改变产品的质量或者质量标准。
在生产无菌产品时，在传统填充区增加屏障，以防止IPC人员干扰经过验证的合格的填充区。
3.生产工艺，批量和设备：
以下工艺发生改变：
在非无菌条件下增加过筛的步骤用以除掉团块。
变更速释口服固体制剂或液体制剂的混合时间（用于混合粉末或颗粒）
变更速释固体口服制剂的干燥时间
生产批量的改变，这个改变是由将几个单独亚批的中间物料混合后引起的。前提是所有混合后的批次都满足已批准的IPC标准，并且混合后的下一工序不会受到影响，生产过程可追溯。
无菌生产工艺中的设备发生改变（如新灌装线，新冻干机），当不改变已批准的工艺和IPC标准时，新设备的设计和操作原理必须与之前的设备一样。
增加相同的工艺线，以便于原料药和制剂生产工艺过程中可以平行操作，必须保证对IPC限度或产品质量标准无影响。
对于无菌产品，可以增加，减少或者改变再过滤的再加工的方案，以解决由于滤膜完整性测试失败而引起的生物负载的问题
可以减少开放性处理步骤的次数或者人工操作步骤来降低产品的风险，但不能改变其他工艺（如采用无菌连接设备来取代火焰保护程序）
对于无菌产品，在已经验证的参数范围内变更过滤工艺参数的范围（如流速，压力，时间或者体积，但不改变孔径），不需要对新范围再进行验证。
在生产无菌产品时，将某一合格的消毒室（环氧乙烷，高压灭菌器）变更为另一相同设计和操作原理的无菌室用于制备包装系统，工艺设备的“变更的零件”的灭菌和产品的终端灭菌，前提是新的操作室和装载配置是经过验证并在之前的验证参数内。变更验证参数不属于此情况。
4.质量标准
在辅料质量标准中增加新的检测项 变更原料药，制剂产品或药典辅料的质量标准，使其符合药典标准。前提是该变更不会放宽可接受标准或者删除某一检测项。
不适合在年报中体现的质量标准的变更包括已批准NDAs或ANDAs中含量，杂质，降解产物，成品有关物质或者生物活性检测方法的变更。此类变更需要递交补充申请（PAS）。
改变已批准的分析方法，前提是修改的方法维持原有的方法学原理并对原料药或制剂提供等价或更严格的保障。产品鉴别，规格，质量，纯度或效能等特性如其所要求不会发生改变，可接受标准不会改变（如改变HPLC方法中流速或者样品制备方法）
取代某一非专属性的鉴别方法，使其更具区分能力（新方法的可接受标准以范围的形式表示）。
增加中控检测
用其他更为合适的方法来取代混合均匀度或中间过程的均一性检测来保证混合的充分性。
修订片剂的硬度（如检测结果的可接受标准，或者改变不同的分析方法及相应的可接受标准），前提是对已获批的溶出分析方法，可接受标准或溶出曲线没有影响。
增加包装材料的检测以提高产品质量保障。
收窄已经获批的原料药，制剂产品，制剂处方组成或中控物质的可接受标准
5.容器/密闭系统
变更非无菌原料药（固体，半固体或液体）的包装系统，前提是新的包装系统在不会增加可萃取物质（半固体或液体）的风险，并能提供与之前的包装材料等价的保护特性。
使用或者改变合同加工商（CMO）来清洗，干燥或者硅化产品的塞子或者包装系统的某一部分，前提是申请者能证明CMO的工艺是经过验证的或者CMO工厂通过了申请者（或者其他申请者赞助的团体）的审计且符合CGMP的要求
对于固体口服制剂，改变某种一级包装材料，该成分已被其他CDER已批准的产品用过：
改变干燥剂的型号，该干燥剂已被其他获批的产品使用且更适合本产品。
减少装瓶的填充空间，如纤维材料（合适种类的棉花，人造纤维，聚酯等）可用于减少产品包装中的空隙空间。
对于透皮制剂，变更玻璃供应商但不改变玻璃的种类，涂层，也不改变包装的尺寸。
变更螺旋盖（套圈或翻盖/顶封），前提是颜色不改变，并用验证过的方法来证明其包装完整性。需要注意的是，如果翻盖或者顶封颜色发生了改变需要确保其与已经建立的颜色条形码系统相符，产品级别需要在年报中阐明。
改变或去掉公司商标或其他螺旋密封盖上的标记来符合药典要求
6.标签变更
修订产品标签来反应包衣组成中非活性成分的定性变化，如以上1.2中所述。应该在执行此变更时把的变更的最终的产品标签（SPL）提交给药政当局。以便于在eLIST中更新现行的产品信息，这有助于确保产品使用的安全性和有效性。
通过变更产品标签来修订CMC相关的变更信息在本指南中有讨论。如果变更包含产品标签的修订，6.1中提到内容都将适用。
7.其他变更
根据已批准的稳定性方案，基于注册批或者商业批的稳定系数据来延长原料药的复验期或制剂产品的有效期。
对于速释固体制剂，如果进行了溶出测试，可以从已批准的稳定性方案中去掉鉴别和硬度检测。
根据一个已经获批的“grouped supplement”变更来对其他的相似产品进行同样的变更。附件B：FDA SUPAC-IR,SUPAC-MR,SUPAC-SS和已经批准的NDA和ANDA变更指南中提到的需要在年报中报告的变更实例
1.组成和组分
为了符合药典的要求而做的任何变更，除了放宽可接受标准或者去掉某一检测项（见21CFR 314.70(c)(2)(iii)）
完全或部分去掉影响产品颜色，气味或者香味的成分而不改变产品的质量标准。需要注意的是去掉或改变颜色，气味或香味可能影响产品的外观或制剂的其他显著的感官特性（可见外观，味道，香味，气味或者香气）。这些变更可能会影响标签中“How the Drug Product is Supplied”的部分。在这种情况下，附件A中第6部分标签变更可适用。
变更非控释辅料在处方中的用量，以占总处方组成百分比（w/w）的形式表示，与最初的申请相比变化不超过以下范围：填充剂±5%，崩解剂（淀粉±3%，其他±1%），粘合剂±0.5%，润滑剂（硬脂酸钙或硬脂酸镁±0.25%，其他±1%），助流剂（滑石粉±1%，其他±0.1%），包衣粉±1%。
变更辅料的供应商，需要保证辅料的级别和质量标准不改变
在控释制剂中，任何一种控释材料占总控制材料比例的改变,以百分比（w/w）的形式来表现, 应该小于或等于5%。变更后，制剂总片重和质量标准应该保持不变。
2.生产地址
如果新的生产地址通过CGMP的检查，以下变更可以在年报中体现：
变更固体制剂二级包装，贴标签，油墨印字的地点或者原料药中间体而非最后一步中间体的生产和加工地点
在同一个工厂内变更生产地点（包括产品的终端灭菌），不管是单独生产还是合作生产的工厂，不包括放大变更，生产工艺及设备的变更，产品组成和组分的变更。SOP，具备生产工艺经验的操作人员，环境条件和控制，生产批记录都保持不变，只有行政信息和同一个工厂的生产地点发生改变。3.生产工艺
对于药品而言，可以变更具有相同设计和操作原理，容量，批量的设备（增加或减少），除天然蛋白质原料药和蛋白质制剂以外。
可以变更液体制剂中组分的添加顺序（除活性成分外）或者配制某单元操作中的溶液（如制粒液）时，改变其组分添加顺序
4.质量标准
4.1.对于原料药或者制剂成品，增加或者修订某一可替换的分析方法，前提是要保证该分析方法与已经获批的分析方法相比，具有等效的或者更优的鉴定，规格，质量，纯度，效能检测方法。或者删掉一个可替换的分析方法。
4.2 可以变更以下物质的检测方法，如原料药合成中用到的原材料，在最终原料药中间体之前引入的起始物料，最终中间体前的中控物料或原料药中间体（不包括最终中间体），其前提是该分析方法与之前获批的分析方法相比具有相同的或更优的检测能力。
第四篇：十八大报告中英文对照
政府工作报告
——2013年3月5日在第十二届全国人民代表大会第一次会议上 国务院总理 温家宝
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：
现在，我代表国务院，向大会报告过去五年的政府工作，并对今年工作提出建议，请各位代表审议，并请全国政协委员提出意见。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、过去五年工作回顾
I.Review of Work in the Past Five Years
第十一届全国人民代表大会第一次会议以来的五年，是我国发展进程中极不平凡的五年。我们有效应对国际金融危机的严重冲击，保持经济平稳较快发展，国内生产总值从26.6万亿元增加到51.9万亿元，跃升到世界第二位；公共财政收入从5.1万亿元增加到11.7万亿元；累计新增城镇就业5870万人，城镇居民人均可支配收入和农村居民人均纯收入年均分别增长8.8%、9.9%；粮食产量实现“九连增”；重要领域改革取得新进展，开放型经济达到新水平；创新型国家建设取得新成就，载人航天、探月工程、载人深潜、北斗卫星导航系统、超级计算机、高速铁路等实现重大突破，第一艘航母“辽宁舰”入列；成功举办北京奥运会、残奥会和上海世博会；夺取抗击汶川特大地震、玉树强烈地震、舟曲特大山洪泥石流等严重自然灾害和灾后恢复重建重大胜利。我国社会生产力和综合国力显著提高，人民生活水平和社会保障水平显著提高，国际地位和国际影响力显著提高。我们圆满完成“十一五”规划，顺利实施“十二五”规划。社会主义经济建设、政治建设、文化建设、社会建设、生态文明建设取得重大进展，谱写了中国特色社会主义事业新篇章。
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: 一是有效应对国际金融危机，促进经济平稳较快发展。过去五年，我们是在持续应对国际金融危机严重冲击中走过来的。这场危机来势之猛、扩散之快、影响之深，百年罕见。我们沉着应对，及时果断调整宏观调控着力点，出台进一步扩大内需、促进经济平稳较快增长的十项措施，全面实施一揽子计划。两年新增4万亿元投资，其中中央财政投资1.26万亿元，主要用于保障性安居工程、农村民生工程、基础设施、社会事业、生态环保、自主创新等方面建设和灾后恢复重建。五年来，新建各类保障性住房1800多万套，棚户区改造住房1200多万套；完成大中型和重点小型水库除险加固1.8万座，治理重点中小河流2.45万公里，新增节水灌溉面积770万公顷；新增铁路里程1.97万公里，其中高速铁路8951公里，京沪、京广、哈大等高铁和一批城际铁路相继投入运营；新增公路60.9万公里，其中高速公路4．2万公里，高速公路总里程达9.56万公里；新建机场31个；新增万吨级港口泊位602个；一批跨江跨海大桥、连岛工程相继建成；西气东输、西电东送、南水北调等重大工程顺利推进或建成；非化石能源快速发展，水电、风电装机位居世界第一；重建后的汶川、玉树、舟曲等灾区发生了翻天覆地的变化。这些举世瞩目的成就，对我们有效应对国际金融危机严重冲击发挥了至关重要的作用，为经济社会长远发展打下了坚实基础，已经并将继续造福亿万人民。
我们始终注重处理好保持经济平稳较快发展、调整经济结构和管理通胀预期的关系，增强宏观政策的前瞻性、科学性、有效性，注意把握好政策的取向、力度和重点。在国际金融危机冲击最严重时，果断实施积极的财政政策和适度宽松的货币政策，综合运用多种财政政策工具，增加政府支出，实行结构性减税；有效运用存款准备金率、利率等货币政策工具，保持货币信贷合理增长。根据宏观经济走势的变化，我们及时调整政策力度，适时退出刺激政策，实施积极的财政政策和稳健的货币政策。在财政政策运用上，坚持统筹兼顾，注重综合平衡。财政赤字占国内生产总值的比重从2009年的2.8%降到去年的1.5%左右，赤字率和债务负担率保持在安全水平。加强地方政府性债务全面审计和地方政府融资平台管理，有效控制经济运行中的风险隐患。在货币政策运用上，始终注意把握稳增长、控物价和防风险之间的平衡。金融体系运行稳健，银行业风险抵御能力持续增强，资本充足率从2007年底的8.4%提升到去年底的13.3%，不良贷款率由6.1%下降到0.95%。坚持搞好房地产市场调控不动摇，遏制了房价过快上涨势头。2012年，在世界各大经济体增长全面减速、各种风险不断暴露的情况下，我们合理把握政策力度，保持财政预算支出规模不变，优化支出结构，扭转经济下滑趋势，全面实现年初确定的主要目标，国内生产总值增长7.8%，城镇新增就业1266万人，居民消费价格涨幅回落到2.6%，为今年经济发展打下好的基础。
这五年，我国宏观经济总体上保持增速平稳较快、物价相对稳定、就业持续增加、国际收支趋于平衡的良好态势，国内生产总值年均增长9.3%，显著高于同期全球和新兴经济体的增速，通货膨胀率远低于其他新兴经济体。我国经济稳定，充满活力。
回首这五年，面对国际经济形势复杂多变、持续低迷的严峻挑战，中央科学判断、果断决策，有效避免了我国现代化进程因巨大的外部冲击而出现大的波折，实践证明这些决策部署是完全正确的。
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.二是加快经济结构调整，提高经济发展的质量和效益。坚持实施扩大内需战略，内需对经济增长的贡献率明显提高，经常项目顺差占国内生产总值的比重从10.1%下降到2.6%。居民消费结构加快升级。2012年底，城镇和农村人均住房面积32.9平方米、37.1平方米，分别比2007年增加2.8平方米和5.5平方米；城镇居民每百户拥有家用汽车21.5辆，比2007年增加15.5辆；旅游、文化消费大幅增加。坚持走中国特色新型工业化道路，大力推进产业转型升级。我国制造业规模跃居全球首位，高技术制造业增加值年均增长13.4%，成为国民经济重要先导性、支柱性产业；清洁能源、节能环保、新一代信息技术、生物医药、高端装备制造等一批战略性新兴产业快速发展。产品质量整体水平不断提高。服务业增加值占国内生产总值比重提高2.7个百分点，成为吸纳就业最多的产业。扎实推进节能减排和生态环境保护。五年累计，共淘汰落后炼铁产能1.17亿吨、炼钢产能7800万吨、水泥产能7.75亿吨；新增城市污水日处理能力4600万吨；单位国内生产总值能耗下降17.2%，化学需氧量、二氧化硫排放总量分别下降15.7%和17.5%。修订环境空气质量标准，增加细颗粒物PM2.5等监测指标。推进天然林保护、退耕还林、防沙治沙等重点生态工程建设，五年累计完成造林2953万公顷，治理沙漠化、石漠化土地1196万公顷，综合治理水土流失面积24.6万平方公里，整治国土面积18万平方公里。深入实施区域发展总体战略，颁布实施全国主体功能区规划，制定西部大开发新十年指导意见和一系列区域发展规划，加快推进西藏、新疆等地区跨越式发展，制定实施新十年农村扶贫开发纲要，将扶贫标准提高到2300元（2010年不变价），加强集中连片特殊困难地区扶贫攻坚。中西部和东北地区主要发展指标增速高于全国平均水平，东部地区产业转型升级步伐加快，各具特色、良性互动的区域发展格局正在形成。积极稳妥推进城镇化，五年转移农村人口8463万人，城镇化率由45.9%提高到52.6%，城乡结构发生了历史性变化。城乡、区域发展的协调性明显增强。
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“三农”工作，巩固和加强农业基础地位。我们坚持在工业化、信息化、城镇化深入发展中同步推进农业现代化，集中力量办成了一些关系农业农村长远发展、关系农民切身利益的大事。加大财政投入，中央财政“三农”累计支出4.47万亿元，年均增长23.5％。建立健全种粮农民补贴制度和主产区利益补偿机制，补贴标准逐年提高，覆盖范围不断扩大，补贴资金从2007年的639亿元增加到2012年的1923亿元。加强农村金融服务，涉农贷款余额从2007年末的6.12万亿元增加到2012年末的17.63万亿元。实行粮食最低收购价政策，小麦、稻谷最低收购价累计提高41.7%到86.7%。加强耕地保护，维护农民权益，为完善农村集体土地征收补偿制度做了大量准备工作。加快推进农业科技进步和现代农业建设，加大对良种繁育、动植物疫病防控、基层农技推广的支持力度。大力兴修水利，开展农村土地整治，建设高标准农田，耕地面积保持在18.2亿亩以上。粮食综合生产能力跃上新台阶，粮食总产量连续6年稳定在万亿斤以上并逐年增加。加强农村水电路气等基础设施建设，新建改建农村公路146.5万公里，改造农村危房1033万户，解决了3亿多农村人口的饮水安全和无电区445万人的用电问题，农村生产生活条件不断改善。积极引导农村富余劳动力转向非农产业，农民人均纯收入持续较快增长，2010年以来城乡居民相对收入差距逐步缩小。深化农村综合改革。集体林权制度主体改革基本完成，全面推进农村集体土地确权颁证工作，开展农村土地承包经营权登记试点。农业农村发展的好形势，为应对国际金融危机和各种自然灾害严重冲击、稳定经济社会发展大局提供了重要支撑。
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.四是坚持实施科教兴国战略，增强经济社会发展的核心支撑能力。我们加快实施国家中长期科学和技术发展规划纲要，制定实施国家中长期教育改革和发展规划纲要、国家中长期人才发展规划纲要和国家知识产权战略，推动科技、教育、文化事业全面发展，为国家长远发展奠定了坚实基础。
优先发展教育事业。国家财政性教育经费支出五年累计7.79万亿元，年均增长21.58%，2012年占国内生产总值比例达到4%。教育资源重点向农村、边远、民族、贫困地区倾斜，教育公平取得明显进步。全面实现城乡九年免费义务教育，惠及1.6亿学生。实施学前教育三年行动计划，“入园难”问题有所缓解。国家助学制度不断完善，建立了家庭经济困难学生资助体系，实现从学前教育到研究生教育各个阶段全覆盖，每年资助金额近1000亿元，资助学生近8000万人次。实施中等职业教育免学费政策，覆盖范围包括所有农村学生、城市涉农专业学生和家庭经济困难学生。初步解决进城务工人员随迁子女在城市接受义务教育问题，现有1260万农村户籍孩子在城市接受义务教育。实施惠及3000多万农村义务教育阶段学生营养改善计划。完成中小学校舍安全工程。加快职业教育基础能力和特殊教育基础设施建设。义务教育学校实施绩效工资，在教育部直属师范大学实行师范生免费教育，加强了农村教师队伍建设。全面提高教育质量和水平，高等教育毛入学率提高到30%。国民受教育程度大幅提升，15岁以上人口平均受教育年限达到9年以上。大力推动自主创新。中央财政用于科技的投入五年累计8729亿元，年均增长超过18%。全社会研究与试验发展经费支出占国内生产总值的比重由2007年的1.4%提高到2012年的1.97%，企业研发活动支出占比超过74%。出台深化科技体制改革加快国家创新体系建设的意见。深入实施国家技术创新工程和知识创新工程，扎实推进国家科技重大专项，新建一批国家工程中心、重点实验室和企业技术中心。加强基础研究和前沿探索，突破一批关键核心技术，填补了多项重大产品和装备的空白。
深入实施人才强国战略。以高层次、高技能人才为重点，加强各类人才队伍建设，专业技术人才、高技能人才分别增加860万人和880万人，留学回国人员达到54万人。大力加强文化建设。覆盖城乡的公共文化设施网络体系初步建成，博物馆、图书馆、文化馆（站）实现免费开放。国有经营性文化单位转企改制任务基本完成，公益性文化事业单位内部机制改革不断深化。哲学社会科学、新闻出版、广播影视、文学艺术等更加繁荣，文化产业快速发展。文物保护、非物质文化遗产保护和传承取得重要进展。对外文化交流更加活跃。全民健身和竞技体育取得新成绩。
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.五是坚持把人民利益放在第一位，着力保障和改善民生。我们把就业作为保障和改善民生的头等大事，实施积极的就业政策。加强重点人群就业工作，提高职业培训和就业服务水平，五年累计投入就业专项资金1973亿元，实现高校毕业生就业2800万人，城镇就业困难人员就业830万人，保持了就业形势总体稳定。全面推进社会保障体系建设，建立新型农村社会养老保险和城镇居民社会养老保险制度，城乡居民基本养老保险实现了制度全覆盖，各项养老保险参保达到7.9亿人。企业退休人员基本养老金从2004年人均每月700元提高到现在的1721元。妥善解决关闭破产企业退休人员、困难企业职工、国有企业老工伤人员、未参保集体企业退休人员社会保险等问题。深化医药卫生体制改革，建立新型农村合作医疗制度和城镇居民基本医疗保险制度，全民基本医保体系初步形成，各项医疗保险参保超过13亿人，加强城乡基层医疗卫生服务体系建设，建立基本药物制度并在基层医疗机构实施，公立医院改革试点稳步推进。国民健康水平进一步提高，人均预期寿命达到75岁。健全城乡居民低保、医疗、教育、法律等救助制度，改革完善孤儿保障、流浪儿童救助保护、农村五保供养制度。颁布实施新的中国妇女、儿童发展纲要，依法保障妇女儿童合法权益。建立健全城镇保障性住房制度，覆盖面逐步扩大，2012年底已达到12.5%。社会保障制度建设取得历史性的巨大成就。不断加强和创新社会管理，建立健全应急管理体系，发挥城乡社区自治和服务功能，社会保持和谐稳定。
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.六是深化重要领域改革，增强经济社会发展的内在活力。我们不失时机地推进改革，在一些重要领域取得重大进展。大力推进财税体制改革，完善转移支付制度，全面建立县级基本财力保障机制，基层政府提供基本公共服务的能力有所提高；由公共财政预算、政府性基金预算、国有资本经营预算、社会保险基金预算组成的预算体系框架基本形成，预算外资金全部纳入预算管理；统一内外资企业税制，实现增值税转型，实施成品油价格和税费改革，开展营业税改征增值税试点，改革资源税制度，财税体制对加快转变经济发展方式的促进作用增强。全面深化金融体制改革，国有大型商业银行股份制改革顺利完成，政策性金融机构改革有序推进，农村信用社改革成效明显，银行业新监管标准实施，创业板、股指期货和融资融券业务相继推出，保险业改革开放深入推进，人民币汇率形成机制不断完善，利率市场化和资本项目可兑换改革稳步推进，建立宏观审慎政策框架，扩大人民币在跨境贸易和投资中的使用。我国银行、证券、保险业的抗风险能力和国际竞争力显著提升，为成功应对国际金融危机冲击奠定了坚实基础。国有企业改革不断深化，素质提高，竞争力明显增强。制定鼓励和引导民间投资健康发展的指导意见和实施细则，非公有制经济发展环境不断改善。建立生态补偿制度，开展排污权和碳排放权交易试点。事业单位分类改革积极推进。
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.七是坚定不移扩大对外开放，全面提升开放型经济水平。我们积极应对外部环境的急剧变化，及时出台稳定外需的政策措施，实施市场多元化战略，进出口总额年均增长12.2%，从世界第三位提升到第二位，其中出口额跃居世界第一位，占国际市场份额比2007年提高2个多百分点，进出口结构优化，贸易大国地位进一步巩固。五年累计实际利用外资5528亿美元，利用外资的结构和布局明显优化，质量和水平显著提升。加快实施“走出去”战略，鼓励各类企业开展对外投资和跨国经营，非金融类对外直接投资从2007年的248亿美元上升到2012年的772亿美元，年均增长25.5%，跻身对外投资大国行列。对外开放有力促进了我国经济发展和结构优化，吸收了先进技术和管理经验，增加了就业和职工收入，也为推动世界经济复苏作出了重要贡献。
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.八是切实加强政府自身建设，进一步深化行政体制改革。推进政府机构改革，初步建立职能统一的大部门体制框架。我们始终把实行科学民主决策、坚持依法行政、推进政务公开、健全监督制度、加强廉政建设作为政府工作的基本准则。在规范行政权力运行，建设服务政府、责任政府、法治政府和廉洁政府方面，采取了一系列新举措，迈出了新步伐。坚持科学决策、民主决策、依法决策，健全公众参与、专家论证、风险评估、合法性审查和集体讨论决定等政府决策程序。深化行政审批制度改革，五年中分两轮取消和调整行政审批事项498项，国务院各部门取消和调整的审批项目总数达到2497项，占原有审批项目的69.3%。大力推动政务公开，重点推进财政预算决算公开和公务接待、公务车购置使用、因公出国出境经费公开，让人民群众更加全面地了解政府工作，更加有效地监督政府行为。审计监督的力度越来越大，成效越来越明显。全面加强反腐倡廉建设，加强领导干部廉洁自律的监督管理。探索建立政府绩效管理制度，建立并切实执行以行政首长为重点的行政问责制度，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！
五年来，我们贯彻民族区域自治法，支持少数民族和民族地区发展的政策体系更加完善，民族团结进步事业焕发出新的蓬勃生机。
全面落实宗教信仰自由政策，宗教事务管理的法制化、规范化水平进一步提升。认真贯彻侨务政策，依法保护海外侨胞和归侨侨眷的合法权益，侨务资源的独特优势得到进一步发挥。国防和军队建设开创新局面。中国特色军事变革取得重大成就，军队革命化现代化正规化建设协调推进、全面加强，军事斗争准备不断深化，履行新世纪新阶段历史使命能力显著增强，出色完成一系列急难险重任务。
港澳台工作进一步加强。香港、澳门保持繁荣稳定，同内地交流合作提高到新水平。推动两岸关系实现重大转折，两岸直接双向“三通”全面实现，签署实施两岸经济合作框架协议，形成两岸全方位交往格局，开创两岸关系和平发展新局面。
全方位外交取得新的重大进展。我们积极推进同各大国关系，加强与周边邻国的互利合作关系，顺利建成中国－东盟自贸区，推动上海合作组织等区域合作机制发展，深化同广大发展中国家的传统友谊与合作，积极参与应对国际金融危机、气候变化等全球性问题的国际合作，推动解决国际和地区热点问题，为我国改革发展稳定营造了有利的国际环境，为世界和平稳定发展繁荣作出重要贡献。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、今年经济社会发展的总体要求、主要预期目标和宏观经济政策
II.General Requirements, Major Targets and Macroeconomic Policies for This Year's Economic and Social Development
党的十八大科学总结了过去五年的工作和党的十六大以来的奋斗历程和历史性成就，确定了全面建成小康社会和全面深化改革开放的目标，对进一步推进中国特色社会主义事业作出了全面部署。
2013年是全面贯彻落实党的十八大精神的开局之年，是实施“十二五”规划承前启后的关键一年，是为全面建成小康社会奠定坚实基础的重要一年。我国发展仍处于可以大有作为的重要战略机遇期，经济社会发展具备很多有利条件和积极因素，也面临不少风险和挑战。国际金融危机深层次影响持续显现，世界经济复苏充满不确定性、不稳定性。我们既要看到形势的积极方面，坚定信心，也要看到形势的复杂性，增强忧患意识和紧迫感，兢兢业业、扎扎实实做好工作。
今年工作的总体要求是：深入学习和全面贯彻落实党的十八大精神，高举中国特色社会主义伟大旗帜，以邓小平理论、“三个代表”重要思想、科学发展观为指导，紧紧围绕主题主线，以提高经济增长质量和效益为中心，深化改革开放，实施创新驱动战略，稳中求进，开拓创新，扎实开局，全面推进社会主义经济建设、政治建设、文化建设、社会建设、生态文明建设，实现经济持续健康发展和社会和谐稳定。
今年经济社会发展的主要预期目标是：国内生产总值增长7.5%左右，发展的协调性进一步增强；居民消费价格涨幅3.5%左右；城镇新增就业900万人以上，城镇登记失业率低于4.6%；城乡居民人均收入实际增长与经济增长同步，劳动报酬增长和劳动生产率提高同步；国际收支状况进一步改善。这里，着重对经济增长和物价总水平两个指标作些说明。关于经济增长目标。这是一个综合性指标，各方面高度关注。今年经济增长预期目标定为7.5%左右，主要基于两方面考虑：一方面，要继续抓住机遇、促进发展。这些年，我国制造业积累了较大产能，基础设施状况大为改善，支撑能力明显增强，储蓄率较高，劳动力总量仍然很大。必须优化配置和利用生产要素，保持合理的增长速度，为增加就业、改善民生提供必要条件，为转方式、调结构创造稳定环境；必须使经济增长与潜在增长率相协调，与生产要素的供给能力和资源环境的承受能力相适应。另一方面，要切实按照科学发展观的要求，引导各方面把工作重心放到加快转变经济发展方式和调整经济结构上，放到提高经济增长的质量和效益上，推动经济持续健康发展。综合权衡，今年的经济增长目标定为7.5%左右是必要的、适宜的，实现这个目标需要付出艰苦努力。
关于物价总水平。保持物价总水平基本稳定始终是宏观调控的重要目标。去年居民消费价格涨幅回落到2.6%，这是我们控制通货膨胀取得的一个重要成果，也与经济运行整体态势有关。今年通货膨胀压力仍然较大，主要是：我国土地、劳动力等要素价格，农产品和服务类价格都存在上涨压力；主要发达国家实行宽松货币政策并不断加码，输入性通货膨胀压力不容忽视；理顺能源资源价格需要留出一定空间；去年价格上涨的翘尾影响约有1个百分点。把居民消费价格涨幅控制在3.5%左右，是充分考虑各方面因素后作出的选择。要切实保障重要商品供给，搞活流通，降低物流成本，加强市场价格监管，保持物价总水平基本稳定。
实现上述目标，必须继续实施积极的财政政策和稳健的货币政策，保持政策连续性和稳定性，增强前瞻性、针对性和灵活性。
继续实施积极的财政政策。更好地发挥积极财政政策在稳增长、调结构、促改革、惠民生中的作用。一是适当增加财政赤字和国债规模。今年拟安排财政赤字1.2万亿元，比去年预算增加4000亿元，其中中央财政赤字8500亿元，代地方发债3500亿元。这主要是考虑到结构性减税的滞后效应，今年财政收入增长不会太快，但财政刚性支出增加，特别是要增加保障改善民生支出，保持对经济增长和结构调整的支持力度，适当扩大财政赤字和国债规模是必要的。同时，目前我国债务负担率相对较低，今年增加赤字后，赤字率在2%左右，总体上处于安全水平。二是结合税制改革完善结构性减税政策。重点是加快推进营业税改征增值税试点工作，完善试点办法，适时扩大试点地区和行业范围。三是着力优化财政支出结构。继续向教育、医药卫生、社会保障等民生领域和薄弱环节倾斜，严格控制行政经费等一般性支出，勤俭办一切事业。中央预算内投资主要投向保障性安居工程，农业、水利、城市管网等基础设施，社会事业等民生工程，节能减排和生态环境等领域。四是继续加强地方政府性债务管理。妥善处理债务偿还和在建项目后续融资问题，积极推进地方政府性债务管理制度建设，合理控制地方政府性债务水平。
继续实施稳健的货币政策。把握好促进经济增长、稳定物价和防范金融风险之间的平衡。一是健全宏观审慎政策框架，发挥货币政策逆周期调节作用。广义货币M2预期增长目标拟定为13%左右。综合运用多种货币政策工具，调节市场流动性，保持货币信贷合理增长，适当扩大社会融资规模。完善货币政策传导机制，加强金融监管与货币政策的协调，不断优化监管标准和监管方式。二是促进金融资源优化配置。引导金融机构加大对经济结构调整特别是“三农”、小微企业、战略性新兴产业等的金融支持，满足国家重点在建续建项目资金需求。拓宽实体经济融资渠道，降低实体经济融资成本。促进资本市场稳定健康发展。三是守住不发生系统性和区域性金融风险底线。引导金融机构稳健经营，加强对局部和区域性风险以及金融机构表外业务风险的监管，提高金融支持经济发展的可持续性。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、对今年政府工作的建议
III.Suggestions for the Work of the Government This Year
结合过去十年特别是近五年工作的体会，对今年政府主要工作提出以下建议。
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）加快转变经济发展方式，促进经济持续健康发展。我国社会主义现代化建设取得的一切成就都建立在经济持续健康发展的基础之上，经济不发展，什么事情都办不成。我国仍处于并将长期处于社会主义初级阶段的基本国情没有变，人民日益增长的物质文化需要同落后的社会生产之间的矛盾这一社会主要矛盾没有变，我国是世界上最大发展中国家的国际地位没有变，发展仍是解决我国所有问题的关键。必须坚持以经济建设为中心，聚精会神搞建设，一心一意谋发展。只要我们牢牢把握发展的重要战略机遇期，尊重发展规律，创新发展理念，破解发展难题，加快转变经济发展方式，在发展中促转变，在转变中谋发展，就一定能实现经济持续健康发展。要坚定不移地把扩大内需作为经济发展的长期战略方针，充分发挥消费的基础作用和投资的关键作用。扩大内需的难点和重点在消费，潜力也在消费。扩大居民消费要在提高消费能力、稳定消费预期、增强消费意愿、改善消费环境上下功夫，不断提高消费对经济增长的拉动力。现阶段，投资在促进经济增长中的作用不可低估。我国既有投资能力，又有投资需求，关键在于选准方向、优化结构、提高投资的质量和效益。政府投资对社会投资具有十分重要的引导作用，但占全社会投资的比重越来越小，必须进一步放宽民间投资市场准入，激发民间投资活力。
要大力推进转变经济发展方式，加快产业结构调整。我国生产力发展水平具有多层次性，回旋余地很大，无论传统产业还是新兴产业、劳动密集型产业还是资金密集型产业，都有发展的空间，重要的是优化资源配置和产业布局，解决产能过剩、核心技术缺乏、产品附加值低的问题，解决低水平重复建设和地区产业结构趋同的问题。必须加快改造提升传统产业，大力发展高新技术产业，提高产品质量和市场竞争力。要加强政策引导，鼓励企业跨行业跨区域跨所有制兼并重组，利用市场倒逼机制促进优胜劣汰。以扩大国内市场应用、重要关键技术攻关为重点，推动战略性新兴产业健康发展。积极推动信息化和工业化融合，加快建设新一代信息基础设施，促进信息网络技术广泛应用。坚持生产性服务业和生活性服务业并重，现代服务业和传统服务业并举，进一步发展壮大服务业。
要顺应人民群众对美好生活环境的期待，大力加强生态文明建设和环境保护。生态环境关系人民福祉，关乎子孙后代和民族未来。要坚持节约资源和保护环境的基本国策，着力推进绿色发展、循环发展、低碳发展。大力推进能源资源节约和循环利用，重点抓好工业、交通、建筑、公共机构等领域节能，控制能源消费总量，降低能耗、物耗和二氧化碳排放强度。要加快调整经济结构和布局，抓紧完善标准、制度和法规体系，采取切实的防治污染措施，促进生产方式和生活方式的转变，下决心解决好关系群众切身利益的大气、水、土壤等突出环境污染问题，改善环境质量，维护人民健康，用实际行动和成效让人民看到希望。要做好气象、地质、地震等方面工作，提高防灾减灾能力。优化国土空间开发格局，合理控制开发强度，调整空间结构。加强海洋综合管理，发展海洋经济，提高海洋资源开发能力，保护海洋生态环境，维护国家海洋权益。
要继续深入实施区域发展总体战略，促进区域经济协调发展。充分发挥各地比较优势，统筹规划、分类指导，优先推进西部大开发，全面振兴东北地区等老工业基地，大力促进中部地区崛起，积极支持东部地区率先发展，加大对革命老区、民族地区、边疆地区、贫困地区扶持力度，深入推进集中连片特殊困难地区扶贫攻坚。
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）强化农业农村发展基础，推动城乡发展一体化。近些年是我国农业发展最快、农村面貌变化最大、农民得到实惠最多的时期。当前，农业农村发展进入一个新阶段，呈现出农业生产综合成本上升、农产品供求结构性矛盾突出、农村社会结构深刻变动、城乡发展加快融合的态势，全面建成小康社会的重点难点仍然在农村。必须坚持把解决好“三农”问题作为全部工作的重中之重，这是历史经验的科学总结，既管当前，也管长远，是长期指导思想。农村土地制度关乎农村的根本稳定，也关乎中国的长远发展，其核心是要保障农民的财产权益，底线是严守18亿亩耕地红线。要坚持以家庭承包经营为基础，支持发展多种形式新型农民合作组织和多层次的农业社会化服务组织，逐步构建集约化、专业化、组织化、社会化相结合的新型农业经营体系，始终注重保护法律赋予农民的财产权利，调动农民积极性。毫不放松粮食生产，建设高标准基本农田，推广先进技术，增强农业综合生产能力，保障粮食和重要农产品的有效供给。要继续加大“三农”投入，加强农村基础设施建设和基本公共服务体系建设，推动城乡发展一体化，形成以工促农、以城带乡、工农互惠、城乡一体的新型工农、城乡关系。要采取有效措施，稳定农业生产经营队伍，积极培育新型农民。
城镇化是我国现代化建设的历史任务，与农业现代化相辅相成。要遵循城镇化的客观规律，积极稳妥推动城镇化健康发展。坚持科学规划、合理布局、城乡统筹、节约用地、因地制宜、提高质量。特大城市和大城市要合理控制规模，充分发挥辐射带动作用；中小城市和小城镇要增强产业发展、公共服务、吸纳就业、人口集聚功能。加快推进户籍制度、社会管理体制和相关制度改革，有序推进农业转移人口市民化，逐步实现城镇基本公共服务覆盖常住人口，为人们自由迁徙、安居乐业创造公平的制度环境。村庄建设要注意保持乡村风貌，营造宜居环境，使城镇化和新农村建设良性互动。
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）以保障和改善民生为重点，全面提高人民物质文化生活水平。2003年抗击突如其来的非典疫情给我们的重要启示之一，就是要统筹经济社会发展。这些年我们在发展经济的同时，更加重视保障改善民生和发展社会事业，政府工作力度之大、财政投入资金之多前所未有。经过不懈努力，我国经济社会发展的协调性明显增强。当前社会结构、社会组织形式、社会利益格局发生深刻变化，社会矛盾明显增多。我们必须把保障和改善民生作为政府一切工作的出发点和落脚点，放在更加突出的位置，着力加强社会建设。
千方百计扩大就业。坚持实施就业优先战略和更加积极的就业政策，通过稳定经济增长和调整经济结构增加就业岗位，加强职业技能培训，提高劳动者就业创业能力，加大投入和政策支持，完善就业服务体系，鼓励创业带动就业，做好重点人群就业工作，促进城乡居民收入持续稳定增长。
完善社会保障制度。坚持全覆盖、保基本、多层次、可持续方针，不断扩大社会保障覆盖面，提高统筹层次和保障水平，加强各项制度的完善和衔接，增强公平性，适应流动性，保证可持续性。今年企业退休人员基本养老金继续提高10%，城乡低保和优抚对象补助标准也进一步提高。要加大对社会养老服务体系和儿童福利机构建设的支持力度。深化医药卫生事业改革发展。巩固完善基本药物制度和基层医疗卫生机构运行新机制，加快公立医院改革，鼓励社会办医。扶持中医药和民族医药事业发展。健全全民医保体系，建立重特大疾病保障和救助机制，全面开展儿童白血病等20种重大疾病保障试点工作。今年新农合和城镇居民基本医疗保险财政补助标准由每人每年240元提高到280元，人均基本公共卫生服务经费标准由25元提高到30元。逐步完善人口政策。坚持计划生育基本国策，适应我国人口总量和结构变动趋势，统筹解决好人口数量、素质、结构和分布问题，促进人口长期均衡发展。重视发展老龄事业，切实保障妇女和未成年人权益，关心和支持残疾人事业。
加强和创新社会管理。改进政府提供公共服务方式，加强基层社会管理和服务体系建设，完善村民自治、城市居民自治制度，保证人民群众依法直接行使民主权利，管理基层公共事务和公益事业。改革社会组织管理体制，引导社会组织健康有序发展。建立健全维护群众权益机制，完善人民调解、行政调解、司法调解联动的工作体系，健全法律援助制度，推动涉法涉诉信访工作改革，畅通和规范群众诉求表达、利益协调、权益保障渠道，健全重大决策社会稳定风险评估和突发事件应急管理机制，维护社会公共安全，促进社会和谐稳定。食品药品安全是人们关注的突出问题，要改革和健全食品药品安全监管体制，加强综合协调联动，落实企业主体责任，严格从生产源头到消费的全程监管，加快形成符合国情、科学合理的食品药品安全体系，提升食品药品安全保障水平。强化公共安全体系和企业安全生产基础建设，遏制重特大安全事故。
加强房地产市场调控和保障性安居工程建设。坚决抑制投机、投资性需求，抓紧完善稳定房价工作责任制和房地产市场调控政策体系，健全房地产市场稳定健康发展长效机制。继续抓好保障性安居工程建设和管理，让老百姓住上放心房、满意房。今年城镇保障性住房基本建成470万套、新开工630万套，继续推进农村危房改造。
教育和科技在现代化建设中具有基础性、先导性、全局性作用，文化是民族的血脉和人民的精神家园，必须放在更加重要的战略位置。
继续推进教育优先发展。目前我国财政性教育经费支出总额已经超过2万亿元，今后还要继续增加，必须把这些钱用好，让人民满意。要进一步深化教育综合改革，切实解决社会普遍关注的重大问题。着力推动义务教育均衡发展，加快发展现代职业教育，提高各级各类教育质量，进一步促进教育公平，为国家发展提供强大的人力资源支撑。深化科技体制改革。推动科技与经济紧密结合，着力构建以企业为主体、市场为导向、产学研相结合的技术创新体系。瞄准关系全局和长远发展的战略必争领域，加强基础研究、前沿先导技术研究。健全科技资源开放共享机制，完善支持科技发展和成果应用转化的财税、金融、产业技术和人才政策，创造公平开放的创新环境，最大限度地调动广大科技工作者的积极性、主动性，激发全社会的创新活力。
扎实推进文化建设。把文化改革发展纳入经济社会发展总体规划，列入各级政府效能和领导干部政绩考核体系，推动文化事业全面繁荣、文化产业快速发展。政府要履行好发展公益性文化事业的责任，加快推进重点文化惠民工程，完善公共文化服务体系。广泛开展全民健身运动，促进群众体育和竞技体育全面发展。
大力加强社会公德、职业道德、家庭美德、个人品德教育。推动诚信体系建设，以政务诚信带动商务诚信和社会诚信，形成良好的社会风尚。
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）以更大的政治勇气和智慧，深入推进改革开放。改革开放是国家发展进步的根本动力。只有坚持改革开放，才能把我们的事业继续推向前进。我国改革已进入攻坚阶段，必须进一步解放思想，全面深化经济体制改革，继续积极稳妥推进政治体制改革，深化文化体制改革，加快推进社会体制改革，加强生态文明制度建设，不断把改革引向深入。要进一步完善社会主义市场经济体制。毫不动摇地巩固和发展公有制经济，毫不动摇地鼓励、支持、引导非公有制经济发展，形成各种所有制经济依法平等使用生产要素、公平参与市场竞争、同等受到法律保护的体制环境。深化国有企业改革以及重点行业改革。加快财税体制改革，理顺中央和地方财力与事权的关系，完善财政转移支付制度，健全公共财政体系，构建地方税体系，促进形成有利于结构优化、社会公平的税收制度。深化金融体制改革，健全促进实体经济发展的现代金融体系，提高银行、证券、保险等行业竞争力，加快发展多层次资本市场，积极发展债券市场，稳步推进利率、汇率市场化改革，扩大人民币跨境使用，逐步实现人民币资本项目可兑换。深化投融资体制改革，推进价格改革，健全资源性产品价格形成机制和生态补偿制度。继续积极稳妥推进事业单位分类改革。收入分配制度是经济社会发展中一项根本性、基础性的制度，是社会主义市场经济体制的重要基石。我们已经制定了深化收入分配制度改革若干意见，要抓紧研究制定具体政策，确保制度建设到位、政策落实到位，有效解决收入分配领域存在的问题，缩小收入分配差距，使发展成果更多更公平地惠及全体人民。
要推进社会主义民主法治建设。坚持人民主体地位，发展更加广泛、更加充分、更加健全的人民民主，保证人民依法享有广泛权利和自由，促进人的全面发展，维护社会公平正义。坚持依法治国，充分尊重宪法和法律的权威，确保决策权、执行权、监督权既相互制约又相互协调，确保国家行政机关按照法定权限和程序行使权力。坚持转变政府职能，推进政企分开、政资分开、政事分开、政社分开，建设职能科学、结构优化、廉洁高效、人民满意的服务型政府。坚持改进工作作风、密切联系群众，提倡艰苦奋斗，厉行勤俭节约，反对铺张浪费，克服形式主义、官僚主义。坚持民主监督、法律监督、舆论监督，健全权力运行制约和监督体系，让人民监督权力，让权力在阳光下运行。坚持反对腐败，加强廉政建设，从制度上改变权力过分集中而又得不到制约的状况，做到干部清正、政府清廉、政治清明。
国内外形势的深刻变化，对我国开放型经济发展提出了新的更高要求。要坚持对外开放的基本国策，实行更加积极主动的开放战略。坚持把稳定出口与扩大进口结合起来，推动对外贸易从规模扩张向质量效益提高转变、从成本和价格优势向综合竞争优势转变，促进形成以技术、品牌、质量、服务为核心的出口竞争新优势；坚持把利用外资与对外投资结合起来，支持企业“走出去”，拓展经济发展的新空间；坚持把深化沿海开放与扩大内陆和沿边开放结合起来，加快形成各具特色、优势互补、分工协作、均衡协调的区域开放格局；坚持把向发达国家开放与向发展中国家开放结合起来，扩大和深化同各方利益汇合点。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中的中英文对照
3Dmax中英文对照表
2010-08-11 13:36
ASSET BROWSER 资源浏览器
ASSIGN VERTEX COLORS 指定顶点颜色
BITMAP/PHOTOMETRIC PATH 位图/光度学路径 CAMERA MATCH 摄影机匹配
CAMERA TRACKER 摄影机跟踪器
MOVIE 影片
MOTION TRACKERS 运动跟踪器
MOVIE STEPPER 影片分节器
ERROR THRESHOLDS 错误阈值
BATCH TRACK 批处理跟踪
POSITION DATA 位置数据
MATCH MOVE 匹配移动
MOVE SMOOTHING 移动平滑
OBJECT PINNING 对象旋转
CHANNEL INFO 通道信息
CLEAN MULTIMATERIAL 清理多维材质
COLLAPSE 塌陷
COLOR CLIPBOARD 颜色剪贴板
COM/DCOM SERVER CONTROL COM/DCOM服务器控制 DYNAMICS 动力学
TIMING & SIMULATION 计时和模拟
FILE LINK MANAGER 文件链接管理器
ATTACH 附加
FILES 文件
PRESETS 预设
FILE LINK SETTINGS 文件链接设置对话框 BASIC 基本选项卡
ADVANCED 高级选项卡
SPLINE RENDERING 样条线渲染选项卡
FIX AMBIENT 固定环境光
FOLLOW /BANK 跟随/倾斜
IFL MANAGER IFL管理器
INSTANCE DUPLICATE MAPS 实例化重复的贴图 LEVEL OF DETAIL 细节级别
LIGHTING DATA EXPORT 照明数据导出器 LIGHTSCAPE MATERIALS LIGHTCAPE材质
LINK INHERITANCE（SELECTED）链接继承（选定）MATERIAL XML EXPORTER 材质XML导出器 MAX FILE FINDER MAX文件查找程序
MAX SCRIPT MAX 脚本语言
MEASURE 测量
MOTION CAPTURE 运动捕捉
OBJECT DISPLAY CULLING 对象显示消隐
PANORAMA EXPORTER 全景导出器
RENDER 渲染面板
VIEWER 查看器
POLYGON COUNTER 多边形计数器
REACTOR 反应堆动力学
RESCALE WORLD UNITS 重缩放世界单位
RESET XFORM 重置变换
RESOURCE COLLECTOR 资源收集器
SHAPE CHECK 图形检查
SKIN UTILTIES 蒙皮工具
STROKES 笔画
SURFACE APPROXIMATION 曲面近似
UVW REMOVE UVW移除
VISUAL MAX SCRIPT 可视化脚本语言
MATERIAL EDITOR 材质编辑器
ANISOTROPIC 各向异性
METAL 金属
MULTI-LAYER 多层
TRANSLUCENT SHADER 半透明明暗器
ADVANCED LIGHTING OVERRIDE 高级照明覆盖材质
ARCHITECTURAL 建筑材质
TEMPLATES 模板
PHYSICAL QUALITIES 物理特性
SPECIAL EFFECTS 特殊效果
ADVANCED LIGHTING OVERRIDE 高级照明覆盖
CUTOUT 裁切（贴图）
BLEND 混合材质
COMPOSITE 合成材质
DOUBLE SIDED 双面材质
MORPHER 变形器材质
MULTI/SUB-OBJECT 多维/子对象材质
SHELLAC 虫漆材质
TOP/BOTTOM 顶/底材质
IND`N PAINT 卡通材质
LIGHTSCAPE MTL LIGHTSCAPE材质
MATTE/SHADOW 无光/投影材质
RAYTRACE 光线跟踪材质
RAYTRACE BASIC PARAMETERS 光线跟踪基本参数
EXTENDED PARAMETERS 扩展参数
RAYTRACER CONTROLS 光线跟踪器控制
SUPER SAMPLING 超级采样
MAPS 贴图
DYNAMICS PROPERTIES 动力学属性
RAYTRACER GLOBAL PARAMETERS 全局光线跟踪设置
INCLUDE/EXCLUDE 包含/排除
SHELL MATERIAL 壳材质
STANDARD 标准材质
SHADER BASIC PARAMETERS 明暗器基本参数
BASIC PARAMETERS 基本参数
EXTENDED PARAMETERS 扩展参数
SUPER SAMPLING 超级采样
MAPS 贴图
DYNAMICS PROPERTIES 动力学属性
DIRECT3D VIEWPORT SHADERS DIRECT3D视口明暗器
XREF MATERIAL 外部参照材质
二维贴图
COORDINATES 贴图坐标参数
NOISE 噪波参数
BITMAP 位图贴图
TILES平铺贴图
CHECKER 棋盘格贴图
COMBUSTION 贴图
GRADIENT 渐变贴图
GRADIENT RAMP 渐变坡度贴图
SWIRL 漩涡贴图
三维贴图
COORDINATES 贴图坐标
CELLULAR 细胞贴图
DENT 凹痕贴图
FALLOFF 衰减贴图
MARBLE 大理石贴图
NOISE 噪波贴图
PARTICLE AGE 粒子年龄
PARTICLE MBLUR 粒子运动模糊贴图
PERLIN MARBLE PERLIN大理石贴图
PLANET 行星贴图
SMOKE 烟雾贴图
SPECKLE 斑点贴图
SPLAT 泼溅贴图
STUCCO 灰涨贴图
WAVES 波浪贴图
WOOD 木材贴图
COMPOSITE 合成贴图
MASK 遮罩贴图
MIX 混合贴图
RGB MULTIPLY RGB相乘贴图
COLOR MODIFIER 颜色修改贴图
OUTPUT 输出
RGB TINT RGB染色
VERTEX COLOR 顶点颜色
OTHER 其它
CAMERA MAP PER PIXEL 每像素摄影机贴图
NORMAL BUMP 法线凹凸
FLAT MIRROR 镜面反射贴图
RAYTRACE 光线跟踪贴图
REFLECT/REFRACT 反射/折射贴图
THIN WALL REFRACTION 薄壁折射贴图
MATERIAL/MAP BROWSER 材质/贴图浏览器
环境与效果
BACKGROUND 背景
GLOBAL LIGHTIG 全局光照
EXPOSURE CONTROL 曝光控制
AUTOMATIC EXPOSURE COTROL 自动曝光控制
LINEAR EXPOSURE CONTROL 线性曝光控制
PSEUDO COLOR EXPOSURE CONTROL 伪彩色曝光控制
ATMOSPHERE 大气
FIER EFFECT 火效果
FOG 雾
VOLUME FOG 体积雾
VOLUME LIGHT 体积光
LENS EFFECTS 镜头效果
GLOW 光晕
RING 光环
RAY 射线
AUTO SECONDARY 自动二级光斑
MANUAL SECONDARY 手动二级光斑
STAR 星形
STREAK 条纹
BLUR 模糊
BRIGHTNELL AND CONTRAST 亮度和对比度
COLOR BALANCE 色彩平衡
FILE OUTPUT 文件输出
FILE GRAIN 胶片颗粒
MOTION BLUR 运动模糊
DEPTH OF FIELD 景深
HAIR AND FUR RENDER EFFECT 毛发渲染效果
渲染
RENDER SHORTCUTS 渲染快捷方式工具栏
RENDER SCENE 渲染场景对话框
COMMON PARAMETERS 公用参数
E-MAIL NOTIFICATIONS 电子邮件通知
SCRIPTS 脚本
ASSIGN RENDERER 指定渲染器
DEFAULT SCANLINE RENDERER 默认扫描线渲染器
VUE FILE RENDERER VUE文件渲染器
RENDER ELEMENTS 渲染元素
RENDER FRAME WINDOW 渲染帧窗口
RENDER OUTPUT 渲染文件输出面板
COMMON PARAMETERS 公用参数
DEFAULT SCANLINE RENDER 默认扫描线渲染器
PRINT SIZE WIZARD打印大小向导
PREVIEW RENDERINGS 预览渲染
RENDER TO TEXTURE 渲染到纹理
GENERAL SETTINGS 常规设置
OBJECT TO BAKE 烘焙对象
OUTPUT 输出
BAKED MATERIAL 烘焙材质
AUTOMATIC MAPPING 自动贴图
ACTIVE SHADE 动态着色渲染
ACTIVE SHADE FLOATER 动态着色浮动窗口
ACTIVE SHADE VIEWPORT 动态着色视口
RAYTRACE 光线跟踪
RAYTRACER SETTINGS 光线跟踪器设置
RAYTRACE GLOBAL EXCLUDE/INCLUDE 光线跟踪排除/包含
ADVANCED LIGHTING 高级照明
LIGHT TRACER 光跟踪器
RADIOSITY 光能传递
ADVANCED LIGHTIG OVERRIDE 高级照明覆盖
NETWORK RENDERING 网格渲染
NETWORK JOB ASSIGNMENT 网络作业分配
BACKBURNER MANAGER 网络渲染管理器
BACKBURNER MANAGER GENERAL PROPERTIESBACKBURNER管理器常规属性 BACKBURNER MANAGER LOGGING PROPERTIESBACKBURNER管理器日志属性 BACKBURNER SERVER 网络渲染服务器
QUEUE MONITOR 队列监视器
COMMAND RENDER 命令行渲染
SAMPLING QUALITY 采样质量
RENDERING ALGORITHMS 渲染算法
CAMERA EFFECTS 摄影机效果
SHADOWS & DISPLACEMENT 阴影与置换
INDIRECT ILLUMINATION 间接照明面板
CAUSTICS AND GLOBAL ILLUMINATION 焦散和全局照明(GI)
FINAL GATHER 最终聚集
PROCESSING 处理面板
TRANSLATOR OPTIONS 转换器选项
DIAGNOSTICS 诊断
DISTRIBUTED BUCKET RENDERING 分布式块状渲染
MATERIAL SHADERS 材质明暗器卷展栏
ADVANCED SHADERS 高级明暗器卷展栏
DGS MATERIAL(PHYSICS_PHEN DGS材质
DGS MATERIAL(PHYSICS_PHEN)PARAMETERS DGS材质参数卷展栏 SUBSURFACE SCATTERING(SSS)曲面散色材质
MENTAL RAY CONNECTIONMENTAL RAY材质卷展栏 3D DISPLACEMENT SHADER 3D置换明暗器
BUMP SHADER 凹凸明暗器
DIELECTRIC MATERIAL SHADER 绝缘材质明暗器
ENVIRONMENT SHADER 环境明暗器
MATERIAL TO SHADER 材质转换为明暗器
SHADER LIST SHADER列表
UV GENERATOR SHADER UV发生器明暗器
UV COORDINATE SHADER UV坐标明暗器
XYZ GENERATOR SHADER XYZ发生器明暗器
XYZ COORDINATE SHADER XYZ坐标明暗器
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