ICH eCTD Specification V 3.2.2 16-July-2008
ICH eCTD Specification................................................................................................................. 1
Introduction ................................................................................................................................. 1
Background.................................................................................................................................. 1
Scope ........................................................................................................................................... 1
Technical Requirements.............................................................................................................. 1
Change Control............................................................................................................................ 1
Appendix 1: Overall Architecture................................................................................................1-1
Guiding Design Principles........................................................................................................1-1
Business Model.........................................................................................................................1-1
Modular Structure of the eCTD................................................................................................1-1
XML Based eCTD....................................................................................................................1-1
Multiple Region Support..........................................................................................................1-2
Life Cycle Management ...........................................................................................................1-2
Appendix 2: The eCTD Submission............................................................................................2-1
Introduction ..............................................................................................................................2-1
The eCTD Submission..............................................................................................................2-1
Directory Structure...............................................................................................................2-1
XML eCTD Instance............................................................................................................2-1
eCTD Template ........................................................................................................................2-1
Formats.....................................................................................................................................2-1
Common Formats.....................................................................................................................2-2
Regional Use of Other Formats................................................................................................2-2
Links.........................................................................................................................................2-2
Presentation ..............................................................................................................................2-2
Checksums................................................................................................................................2-2
Element to File Directory Mapping..........................................................................................2-2
File Extension...........................................................................................................................2-3
Name.........................................................................................................................................2-3
Character encoding...................................................................................................................2-4
References ................................................................................................................................2-4
Appendix 3: General Considerations for the CTD Modules .......................................................3-1
Introduction ..............................................................................................................................3-1
Folder and File Naming Conventions.......................................................................................3-1
Screenshots and Folder Hierarchy............................................................................................3-2
Module 1 Administrative Information and Prescribing Information........................................3-2
Module 2 Summaries................................................................................................................3-2
Module 3 Quality......................................................................................................................3-4
Module 4 Nonclinical Study Reports .......................................................................................3-7
Module 5 Clinical Study Reports ...........................................................................................3-10
Appendix 4: File Organization for the eCTD ..............................................................................4-1
Appendix 5: Region Specific Information Including Transmission and Receipt........................5-1
Introduction ..............................................................................................................................5-1
Region Specific Information: Module 1...................................................................................5-1
Submission Addresses..............................................................................................................5-1
Media........................................................................................................................................5-2
Cover Letter..............................................................................................................................5-2