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 Table of Contents should reflect the granularity of the dossier submitted, taking into account the Annex to the M4 ICH guideline on ‘organisation of the CTD’,published on: http://www.ich.org 内容目录能准确的反映出提交文件的时间的间隔,将M4 ICH提交到附录中 Module 1: 1.0 Cover Let...
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
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 ...
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...
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 Table of Contents of the Submission Including Module 1 ...
EditedbyAlexmengEmail:furenpahrma@gmail CTD文件格式总目录 Tableofcontents 一、organization 二、M4Q(R1) 三、M4S(R2) 四、M4E(R1) 一、Organization组织结构 (一)ORGANISATIONOFTHECOMMONTECHNICALDOCUMENT Module1:AdministrativeInformationandPrescribingInformation 1.1TableofContentsoftheSubmissionIncludingModule1 1.2...
CTD文件格式总目录.pdf,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 Inform
内容提示: Edited by Alexmeng Email furenpahrma@gmail.com 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...
CTD格式介绍(中英文对照)