module:描述每个模块的内容和结构。 2. 索引文件(index file) 索引文件用于快速定位和访问eCTD中的文档,主要包括以下元素: leaf:描述单个文档的基本信息,如文件名、文件类型、哈希值等。 title:文档的标题,用于在界面上显示。 href:文档的相对路径,用于定位文档。 3. 目录结构(directory structure) eCTD的目录结构按...
eCTD包括目录结构(DirectoryStructure)、内容文件(Content Flies)以及基于XML的eCTD实例(XML eCTD Instance)。ICH在官网提供了eCTD空白文件夹结构模板(见图1),申报人可以在此基础上结合eCTD指南要求进行完善,制作药品注册申报资料,并提交至药品监管机构的eCTD信息化系统。 模块(Module,M)1至模块5的内容和格式参考CTD。
欧盟eCTD模块1规范 2017.11 英文.pdf,EU Module 1 eCTD Specification Version 3.0.3 November 2017 Document Control Change Record Version Date Author(s) Comments 0.1 July, 2001 Stan van Belkum Draft 0.2 September, 2001 Stan van Belkum Draft 0.3 October, 2001
eCTD包括目录结构(Directory Structure)、内容文件(Content Flies)以及基于XML的eCTD实例(XML eCTD Instance)。ICH在官网提供了eCTD空白文件夹结构模板(见图1),申报人可以在此基础上结合eCTD指南要求进行完善,制作药品注册申报资料,并提交至药品监管机构的eCTD信息化系统。模块(Module,M)1至模块5的内容和格式参考CTD,...
(1)申报生命周期,如变量和申报线延长/Application lifecycle such as varieties andapplication extension (2)文档生命周期(新加、替换,删除,附件文档)/Dossier lifecycle (addition, replacement, deletion, appendix files) (3)欧盟M1和ASMF的特定结构/Specific structure of EU ...
http://estri.ich.org/eCTD)includesanemptyeCTDfoldertemplateasanexampleofaneCTDsubmissionfolderstructure.ItshowsallofthepossibleModule2-5andcanbepopulatedwiththeapplicantdataandeditedasappropriate(i.e.,addingadditionalsubfoldersorremovingunnecessaryfolders).TheapplicantshouldstilladdtherelevantregionalModule1folders...
Directory structure 目录(mùlù)结构 第十四页,共54页。 XML eCTD instance 第十五页,共54页。 第十六页,共54页。 mf999999-0001 首次(shǒu cì)提交 第十七页,共54页。 第十八页,共54页。 举例说明-MODULE 1 第十九页,共54页。 ADMIN ELEMENTS Administrative information is contained in the admin ...
http://estri.ich.org/eCTD)includesanemptyeCTDfoldertemplateasanexampleofaneCTDsubmissionfolderstructure.ItshowsallofthepossibleModule2-5andcanbepopulatedwiththeapplicantdataandeditedasappropriate(i.e.,addingadditionalsubfoldersorremovingunnecessaryfolders).TheapplicantshouldstilladdtherelevantregionalModule1folders...
The ECTD specification defines the folder structure, contents, XML backbone and the Study Tagging File for clinical and nonclinical studies. The design of the ECTD documentation needs to include considerations of document granularity, templates, shell documents and regional differences in filings; for ...
representing the structure of the submission, it includes links to files and other metadata such as check sum Module 1 information. eCTD Changes 10 The eCTD standard has brought about a number of changes: 1. XML is now used as the Table of Contents – with links to the submitted con...