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 Contents (Modules 2-5) 2.2CTD Introduction 2.3 Quality Overall Su...
1)2)3)4)5)6)7)8)9)10)ImplementationDatesScopeofCTDOverallTableofContentsNumberingSystemPagination(underdiscussion)TransitionalArrangementsRegionalSpecificitiesLineExtensions,Variations&SupplementsQuestionsabouttheCTDMeetingPlans LastUpdateJune13'02 1)ImplementationDatesofCTD OptionalJuly2001:EU,FDA,MHLW(Canada,...
CTD 文件格式总目录 Table of contents 一、organization 二、M4Q(R1) 三、M4S (R2 ) 四、M4E(R1) 一、 Organization 组织结构 (一)ORGANISATION OF THE COMMON TECHNICAL DOCUMENT Module 1: Administrative Information and Prescribing Information 1.1 Table of Contents of the Submission Including Module 1 1.2...
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 Technical Document Summaries 2.1 CommonTechnical Document Table of ...
CTD 文件格式总目录 <br/> <br/> Table of contents <br/> 一、organization <br/> 二、M4Q(R1) <br/> 三、M4S(R2) <br/> 四、
2.1 CTD Table of Contents (Module 2 – 5) CTD文件目录(2-5模块) 2.2 Introduction 简介 2.3 Quality Overall Summary – Introduction 质量摘要-附录 2.3.S Quality Overall Summary – Drug Substance 质量摘要-原料药 2.3.P Quality Overall Summary – Drug Product 质量摘要-药品 2.3.A Qualit...
Module 2.1Common Technical Document Tableof Contents (Modules 2 – 5)通用技术文件目录(模块2-5) Module 2: Common Technical Document Summaries通用技术文件摘要 2.1 CTD Table of Contents (Module 2 – 5)CTD文件目录 2.2 CTD IntroductionCTD简介 2.3 Quality Overall Summary质量摘要 2.4 Nonclinical Overview...
CTD中文版.doc,European Union 欧盟 Administrative Information and Prescribing Information 行政信息和法规信息 Edition May 2008 2008年5月版 Module 1 Table of Content 模块1 内容简介 1.0 Cover Letter 封面1.1 Comprehensive Table of Contents 内容简介 1.2 Applic
CTD Module 4: Table of Contents and Organization Every CTD module, including Module 4, has a strict and unwavering table of contents (only Module 1 will vary somewhat). Module 4 requires the following table of contents: Module 4: Nonclinical Study Reports: ...
1.1ComprehensivetableofcontentsLetterofapplication01CoverLetter02Lifecyclemanagementtrackingtable03Responsetorequestforinformation.1Comprehensivetableofcontents.2Applicationforms21Applicationform22Pre-submissiondetails23Patentcertification24Changeinsponsor.3Medicineinformationandlabelling31Productinformationandpackageinsert311312Prod...