ICH M8 "Specification for Submission Formats for eCTD" - Step 4 page

Background
The ICH M2 EWG has previously developed specifications for submission format as a part eCTD v3.2.2 Specification.  As M8 EWG developed eCTD v4.0, the group agreed to separate the specifications for submission format from the eCTD v4.0 Implementation Guide because the submission format is independent from the eCTD v4.0 message specifications.

ICH Step 4  
ICH Step 4 is an ICH step where the ICH Assembly agrees that there is sufficient consensus on the Guideline.

Step 4 Specification for Submission Formats for eCTD (Step 4) 
To download the document, click here.
The document inherits the content of the specifications for submission format previously covered in the eCTD v3.2.2 Specification, and has been updated based on change requests - e.g. file size, page margins, bookmarks and study dataset files. The latest version (v1.1) was endorsed by the ICH Assembly at the November 2016 ICH Meeting.

Change Control

 

Last updated: January 2017