CTD格式介绍(中英文对照)

1、INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE 人用药物注册技术要求国际协调会议 ICHICH HHARMONISEDARMONISED T TRIPARTITERIPARTITE G GUIDELINEUIDELINE ICHICH 三方协调指南三方协调指南 T THEHE C COMMONOMMON T TECHNICALECHNICAL D DOCUMENTOCUMENT FORFOR THETHE R

2、 REGISTRATIONEGISTRATION OFOF P PHARMACEUTICALSHARMACEUTICALS FORFOR HHUMANUMAN UUSESE: : 人用药物注册通用技术文件人用药物注册通用技术文件 Q QUALITYUALITY 质量质量 Q QUALITYUALITY O OVERALLVERALL S SUMMARYUMMARY OFOF MMODULEODULE 2 2 MMODULEODULE 3 3 : : Q QUALITYUALITY 模块模块 2 2：质量概要：质量概要 模块模块 3 3：质量：质量 Having reached Step 4 o

3、f the ICH Process at the ICH Steering Committee meeting on 9 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH ICH 指导委员会会议 ICH 进程第 4 步 2000 年 11 月 9 日 该指南建议三方法规处采用 ICH (Numbering and Section Headers have been edited for consistency and use in e-CTD as a

4、greed at the Washington DC Meeting, September 11-12, 2002) 2002 年 9 月 11-12 日华盛顿会议一致通过采用统一编号和标题并在 e-CTD 中使用 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of t

5、he Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. 该指南已经合格的专家工作组研究 并按照 ICH 程序经法规部协商。进程第 4 步最终草案已被欧盟、日本和美国采纳 T THEHE C COMMONOMMON T TECHNICALECHNICAL D DOCUMENTOCUMENT FORFOR THETHE R REGISTRATIONEGISTRATION OFOF P PHARMACEUTICALSHAR

6、MACEUTICALS FORFOR HHUMANUMAN UUSESE: : 人用药物注册通用技术文件人用药物注册通用技术文件 Q QUALITYUALITY 质量质量 Q QUALITYUALITY O OVERALLVERALL S SUMMARYUMMARY OFOF MMODULEODULE 2 2 MMODULEODULE 3 3 : : Q QUALITYUALITY 模块模块 2 2：质量概要：质量概要 模块模块 3 3：质量：质量 ICHICH HHARMONISEDARMONISED T TRIPARTITERIPARTITE G GUIDELINEUIDELINE ICH

7、ICH 三方协调指南三方协调指南 Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH (Numbering and Section Headers have been edited for consistency and use in e-CTD as agreed at the Wash

8、ington DC Meeting, September 11-12, 2002) ICH 指导委员会会议 ICH 进程第 4 步 2000 年 11 月 9 日 该指南建议三方法规处采用 ICH 2002 年 9 月 11-12 日华盛顿会议一致通过采用统一编号和标题并在 e-CTD 中使用 TABLETABLE OFOF CONTENTSCONTENTS 目录目录 MODULE 2 : COMMON TECHNICAL DOCUMENT SUMMARIES.1 2.3 : QUALITY OVERALL SUMMARY (QOS).1 INTRODUCTION .1 2.3.S DRUG

9、SUBSTANCE (NAME, MANUFACTURER).1 2.3.S.1General Information (name, manufacturer). 1 2.3.S.2Manufacture (name, manufacturer) . 1 2.3.S.3Characterisation (name, manufacturer) . 2 2.3.S.4Control of Drug Substance (name, manufacturer) . 2 2.3.S.5Reference Standards or Materials (name, manufacturer) .2 2

10、.3.S.6Container Closure System (name, manufacturer). 2 2.3.S.7Stability (name, manufacturer) . 2 2.3.P DRUG PRODUCT (NAME, DOSAGE FORM).3 2.3.P.1Description and Composition of the Drug Product (name, dosage form) .3 2.3.P.2Pharmaceutical Development (name, dosage form). 3 2.3.P.3Manufacture (name, d

11、osage form) . 3 2.3.P.4Control of Excipients (name, dosage form). 3 2.3.P.5Control of Drug Product (name, dosage form). 3 2.3.P.6Reference Standards or Materials (name, dosage form). 3 2.3.P.7Container Closure System (name, dosage form) . 3 2.3.P.8Stability (name, dosage form) . 3 2.3.A APPENDICES.5

12、 2.3.A.1Facilities and Equipment (name, manufacturer) . 5 2.3.A.2Adventitious Agents Safety Evaluation (name, dosage form, manufacturer). 5 2.3.A.3Excipients . 5 2.3.R REGIONAL INFORMATION.5 MODULE 3 : QUALITY.6 3.1. TABLE OF CONTENTS OF MODULE 3.6 3.2. BODY OF DATA.6 3.2.S DRUG SUBSTANCE (NAME, MAN

13、UFACTURER).6 3.2.S.1General Information (name, manufacturer). 6 3.2.S.1.1Nomenclature (name, manufacturer). 6 3.2.S.1.2Structure (name, manufacturer) . 7 3.2.S.1.3General Properties (name, manufacturer). 7 3.2.S.2Manufacture (name, manufacturer) . 7 3.2.S.2.1Manufacturer(s) (name, manufacturer) . 7

14、3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer). 7 3.2.S.2.3Control of Materials (name, manufacturer). 10 3.2.S.2.4Controls of Critical Steps and Intermediates (name, manufacturer) .10 3.2.S.2.5Process Validation and/or Evaluation (name, manufacturer).10 3.2.

15、S.2.6Manufacturing Process Development (name, manufacturer) .11 3.2.S.3Characterisation (name, manufacturer) . 11 3.2.S.3.1Elucidation of Structure and other Characteristics (name, manufacturer). 11 3.2.S.3.2Impurities (name, manufacturer) . 12 3.2.S.4Control of Drug Substance (name, manufacturer) .

16、 12 3.2.S.4.1Specification (name, manufacturer). 12 3.2.S.4.2Analytical Procedures (name, manufacturer). 12 3.2.S.4.3Validation of Analytical Procedures (name, manufacturer).12 3.2.S.4.4Batch Analyses (name, manufacturer) . 12 3.2.S.4.5Justification of Specification (name, manufacturer) .12 3.2.S.5R

17、eference Standards or Materials (name, manufacturer) .12 3.2.S.6Container Closure System (name, manufacturer). 12 3.2.S.7Stability (name, manufacturer) . 13 3.2.S.7.1Stability Summary and Conclusions (name, manufacturer).13 3.2.S.7.2Post-approval Stability Protocol and Stability Commitment (name, ma

18、nufacturer). 13 3.2.S.7.3Stability Data (name, manufacturer). 13 3.2.P DRUG PRODUCT (NAME, DOSAGE FORM).13 3.2.P.1Description and Composition of the Drug Product (name, dosage form) .13 3.2.P.2Pharmaceutical Development (name, dosage form). 15 3.2.P.2.1Components of the Drug Product (name, dosage fo

19、rm).15 3.2.P.2.1.1Drug Substance (name, dosage form). 15 3.2.P.2.1.2Excipients (name, dosage form). 15 3.2.P.2.2Drug Product (name, dosage form) . 15 3.2.P.2.2.1Formulation Development (name, dosage form). 15 3.2.P.2.2.2Overages (name, dosage form). 15 3.2.P.2.2.3Physicochemical and Biological Prope

20、rties (name, dosage form).15 3.2.P.2.3Manufacturing Process Development (name, dosage form) .15 3.2.P.2.4Container Closure System (name, dosage form). 16 3.2.P.2.5Microbiological Attributes (name, dosage form). 16 3.2.P.2.6Compatibility (name, dosage form) . 16 3.2.P.3Manufacture (name, dosage form)

21、 . 16 3.2.P.3.1Manufacturer(s) (name, dosage form) . 16 3.2.P.3.2Batch Formula (name, dosage form) . 16 3.2.P.3.3Description of Manufacturing Process and Process Controls (name, dosage form). 16 3.2.P.3.4Controls of Critical Steps and Intermediates (name, dosage form).17 3.2.P.3.5Process Validation

22、and/or Evaluation (name, dosage form).17 3.2.P.4Control of Excipients (name, dosage form). 17 3.2.P.4.1Specifications (name, dosage form). 17 3.2.P.4.2Analytical Procedures (name, dosage form). 17 3.2.P.4.3Validation of Analytical Procedures (name, dosage form).17 3.2.P.4.4Justification of Specifica

23、tions (name, dosage form). 17 3.2.P.4.5Excipients of Human or Animal Origin (name, dosage form) .17 3.2.P.4.6Novel Excipients (name, dosage form). 18 3.2.P.5Control of Drug Product (name, dosage form). 18 3.2.P.5.1Specification(s) (name, dosage form). 18 3.2.P.5.2Analytical Procedures (name, dosage

24、form). 18 3.2.P.5.3Validation of Analytical Procedures (name, dosage form).18 3.2.P.5.4Batch Analyses (name, dosage form) . 18 3.2.P.5.5Characterisation of Impurities (name, dosage form).18 3.2.P.5.6Justification of Specification(s) (name, dosage form) .18 3.2.P.6Reference Standards or Materials (na

25、me, dosage form). 18 3.2.P.7Container Closure System (name, dosage form) . 18 3.2.P.8Stability (name, dosage form) . 19 3.2.P.8.1Stability Summary and Conclusion (name, dosage form) .19 3.2.P.8.2Post-approval Stability Protocol and Stability Commitment (name, dosage form). 19 3.2.P.8.3Stability Data

26、 (name, dosage form) . 19 3.2.A APPENDICES.19 3.2.A.1Facilities and Equipment (name, manufacturer) . 19 3.2.A.2Adventitious Agents Safety Evaluation (name, dosage form, manufacturer). 20 3.2.A.3Excipients . 20 3.2.R REGIONAL INFORMATION.20 3.3LITERATURE REFERENCES.21 MODULEMODULE 2 2 : : COMMONCOMMO

27、N TECHNICALTECHNICAL DOCUMENTDOCUMENT SUMMARIESSUMMARIES 模块模块 2 2：通用技术文件概要：通用技术文件概要 2.32.3 : : QUALITYQUALITY OVERALLOVERALL SUMMARYSUMMARY (QOS)(QOS) 2 2.3:.3: 质量概要（质量概要（QOSQOS） The Quality Overall Summary (QOS) is a summary that follows the scope and the outline of the Body of Data in Module 3. Th

28、e QOS should not include information, data or justification that was not already included in Module 3 or in other parts of the CTD. 质量概要是对模块 3 中的主要数据和范围的小结。质量概要不能包括那些已经不在模块 3 或 CTD 其它任何部分中的信息、数据或证明。 The QOS should include sufficient information from each section to provide the Quality reviewer with

29、an overview of Module 3. The QOS should also emphasise critical key parameters of the product and provide, for instance, justification in cases where guidelines were not followed. The QOS should include a discussion of key issues that integrates information from sections in the Quality Module and su

30、pporting information from other Modules (e.g. qualification of impurities via toxicological studies discussed under the CTD- S module), including cross-referencing to volume and page number in other Modules. 质量概要应包括每部分的充足信息，给质量审核者提供模块 3 的概况。质量概要还应重点强调产 品的关键参数并提供，如，没有按照指南进行时的说明。质量概要应包括对来自于质量模块和其 它模块的

31、支持信息（如，在 CTD-S 模块中通过毒理学研究对杂质定量等）关键问题的讨论，包 括交叉引用的其它模块的卷号和页码。 This QOS normally should not exceed 40 pages of text, excluding tables and figures. For biotech products and products manufactured using more complex processes, the document could be longer but normally should not exceed 80 pages of text (e

32、xcluding tables and figures). 质量概要通常不超过 40 页，除表格和数字外。对于生物制品和用更复杂的工艺生产的产品，文 件可以长一些但通常不超过 80 页（除表格和数据外）。 The italicised text below indicates where tables, figures, or other items can be imported directly from Module 3. 模块 3 中说明表格、数字或其它项目的斜体文字可直接引用。 INTRODUCTIONINTRODUCTION 引言引言 The introduction should

33、 include proprietary name, non-proprietary name or common name of the drug substance, company name, dosage form(s), strength(s), route of administration, and proposed indication(s). 引言中应包括原料药的专利商品名、非专利商品名，公司名称、剂型、浓度、用药途径，说明。 2.3.S2.3.SDRUGDRUG SUBSTANCESUBSTANCE (NAME,(NAME, MANUFACTURER)MANUFACTURE

34、R) 2 2.3.s.3.s原料药原料药（名称、厂商名称、厂商） 2.3.2.3.S S. .1 1GeneralGeneral InformationInformation (name,(name, manufacturer)manufacturer) 2 2.3.S.1.3.S.1概要概要（名称名称，厂商厂商） Information from 3.2.S.1 should be included. 应包括 3.2.S.1 中的信息。 2.3.2.3.S S. .2 2ManufactureManufacture (name,(name, manufacturer)manufacturer

35、) 2.3.S.22.3.S.2生产生产（名称名称，厂商厂商） Information from 3.2.S.2 should be included: 应包括 3.2.S.2 中的信息： Information on the manufacturer; 厂商信息； A brief description of the manufacturing process (including, for example, reference to starting materials, critical steps, and reprocessing) and the controls that are

36、 intended to result in the routine and consistent production of material(s) of appropriate quality; 简述生产工艺（包括，如，起始原料、关键步骤和返工等）和可生产出具有优良品质产品的 生产控制。 A flow diagram, as provided in 3.2.S.2.2; 流程图，如 3.2.S.2.2 中所述； A description of the Source and Starting Material and raw materials of biological origin u

37、sed in the manufacture of the drug substance, as described in 3.2.S.2.3; 简要描述原料药生产用的起始原料以及生物来源的原材料及其来源，如 3.2.S.2.3 中所述； A discussion of the selection and justification of critical manufacturing steps, process controls, and acceptance criteria. Highlight critical process intermediates, as described i

38、n 3.2.S.2.4; 讨论关键生产步骤、工艺控制和接受标准的选择和论证，突出关键工艺中间体，如 3.2.S.2.4 中所述； A description of process validation and/or evaluation, as described in 3.2.S.2.5. 工艺验证和/或评估的描述，如 3.2.S.2.5 中所述； A brief summary of major manufacturing changes made throughout development and conclusions from the assessment used to eval

39、uate product consistency, as described in 3.2.S.2.6. The QOS should also cross-refer to the non-clinical and clinical studies that used batches affected by these manufacturing changes, as provided in the CTD-S and CTD-E modules of the dossier. 从对产品的评价到评估产品的一致性得到结论的过程中的重大生产变更的总结，如 3.2.S.2.6 中所述。质量概要还

40、应参照使用受这些生产变更影响的批次进行的非临床临床研究，如文件 CTD-S 和 CTD-E 模块中所述； 2.3.2.3.S S. .3 3CharacterisationCharacterisation (name,(name, manufacturer)manufacturer) 2 2.3.S.3.3.S.3性质性质（名称名称，厂商厂商） For NCE: 注意： A summary of the interpretation of evidence of structure and isomerism, as described in 3.2.S.3.1, should be incl

41、uded. 应包括结构和异构化的证据的简要解说，如 3.2.S.3.1 所述。 When a drug substance is chiral, it should be specified whether specific stereoisomers or a mixture of stereoisomers have been used in the nonclinical and clinical studies, and information should be given as to the stereoisomer of the drug substance that is to

42、 be used in the final product intended for marketing. 当原料药为手性药时，应说明特定的立体异构体或立体异构体混合物是否已被用于非临床和 临床研究，还应给出将用于市场的成品原料药的立体异构体信息。 For Biotech: 生物制品： A description of the desired product and product-related substances and a summary of general properties, characteristic features and characterisation data (

43、for example, primary and higher order structure and biological activity), as described in 3.2.S.3.1, should be included. 应包括对产品及产品有关物质的描述，及对一般性质、特征和特征数据（例如，初级和高级 结构和生物活性）的小结，如 3.2.S.1 中所述; For NCE and Biotech: 注意及生物制品： The QOS should summarise the data on potential and actual impurities arising from

44、 the synthesis, manufacture and/or degradation, and should summarise the basis for setting the acceptance criteria for individual and total impurities. The QOS should also summarise the impurity levels in batches of the drug substance used in the non- clinical studies, in the clinical trials, and in typical batches manufactured by the proposed commercial process. Th