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 Module 5 Structure | MasterControl eCTD Module 1 | MasterControl eCTD Module 2 | MasterControl eCTD Module 3 | MasterControl eCTD Dossier Submissions in Pharma | MasterControl eCTD Viewer, Submissions, Publishing | MasterControl regulatory ectd publishing ...
(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 Module 1 and ASMF (4)美国M1和DMF/USA Module 1 and DMF (5)美国注册文件的格式要求/Format requ...
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。
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,...
Directory structure 目录结构 ? XML eCTD instance ? Content files Directory structure 目录结构 目录结构包括目录和文件 目录和文件的名称应为标示符,应简短,不用表达所有的元数据 ICH的建议 Directory structure 目录结构 XML eCTD instance mf999999-0001 首次提交 举例说明-MODULE 1 ADMIN ELEMENTS Administrative ...
The specification for the eCTD is based upon content defined within the CTD issued by the ICH M4 EWG. The CTD describes the organization of modules, sections and documents. The structure and level of detail specified in the CTD have been used as the basis for defining the eCTD structure and...
http://estri.ich.org/eCTD)includesanemptyeCTDfoldertemplateasanexampleofaneCTDsubmissionfolderstructure.ItshowsallofthepossibleModule2-5andcanbepopulatedwiththeapplicantdataandeditedasappropriate(i.e.,addingadditionalsubfoldersorremovingunnecessaryfolders).TheapplicantshouldstilladdtherelevantregionalModule1folders...
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
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...