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

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 Updated. The document inherits the content of the specifications for submission format previously covered in the eCTD v3.2.2 Specification and the “M2 Specification for PDF Formatted documents in Regulatory Submissions” (link) New, and has been updated based on change requests - e.g. file size, page margins, bookmarks and study dataset files. The latest version (v1.2) was endorsed by the ICH Assembly at the June 2018 ICH Meeting.

Change Control


Last updated: August 2018