经典 中英对照 ICH CTD 目录 Module 1, 2, 3, 4, 5 Module 1: Administrative Information and Prescribing Information 1.1 Table of Contents of the Submission Including Module 1.2 Documents Specific to Each Region (for example, application forms, prescribing information)Module 2: Common Technical ...
Module 1:Administrative Information and Prescribing Information 1.1 Table of Contents of the SubmissionIncluding Module 11.2 Documents Specific to Each Region (forexample, application forms, prescribing information) Module 2:Common Technical Document Summaries 2.1 CommonTechnical Document...
Module 1: Administrative Information and Prescribing Information 1.1Table of Contents of the Submission Including Module 1 1.2 Documents Specific to Each Region (for example, application forms, prescribing information) Module 2: Common Technical Document Summaries 2.1Common Technical Document Table of Conten...
The ICH Harmonised Tripartite Guideline M4(R3) on Organisation of the Common Technical Document ( 1 ) indicates that the Common Technical Document (CTD) Module 1 should contain administrative documents specific to each region, for example, forms, labeling, etc., and that the format be specified...
Module 1:Administrative Information and Prescribing Information 1.1 Table of Contents of the SubmissionIncluding Module 1 1.2 Documents Specific to Each Region (forexample, application forms, prescribing information) Module 2:Common Techn...
张萱20130829 Content 文件金字塔CTD的概念和规则CTD金字塔CTD的应用 举例：ANDA与SFDACTD的对照（ANDA）文件金字塔 提交文件 注册申报 审批 总结文件综合报告 原始数据和记录，基础资料MasterFiles GXP执行 现场检查 文件金字塔 按照文件的生成时期和来源，将药品开发过程中产生的文件归纳成三个...
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 (for example, primary and highe 43、r order structure and biological activity), as described in S3.1,3.2.S.3.1, should be...
1.1TableofContentsoftheSubmissionIncludingModule1 1.2DocumentsSpecifictoEachRegion(forexample,applicationforms, prescribinginformation) Module2:CommonTechnicalDocumentSummaries 2.1CommonTechnicalDocumentTableofContents(Modules2-5) 2.2CTDIntroduction 2.3QualityOverallSummary ...
1.1 Table of Contents of the Submission Including Module 1 1.2 Documents Specific to Each Region (for example, application forms,prescribing information)Module 2: Common Technical Document Summaries 2.1 Common Technical Document Table of Contents (Modules 2-5)2.2 CTD Introduction 2.3 Quality ...
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 (for example, primary 22、and higher order structure and biological activity), as described in 3.2.S.3.1, should be ...