Background
The ICH M2 EWG has previously developed specifications for submission format as a part eCTD v3.2.2 Specification. As the M8 EWG/IWG 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.
Step 4 Specification for Submission Formats for eCTD
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 the “M2 Specification for PDF Formatted documents in Regulatory Submissions” (link), and has been updated based on change requests - e.g. file size, page margins, bookmarks and study dataset files. The latest version (v1.3) was endorsed by the ICH Assembly at the June 2021 ICH Meeting.
Change Control
- The M8 EWG/IWG has implemented a Change Control Process. (PDF document)
- A request for change may be submitted by use of this form. (zipped MS Word document)
- Results of change requests are incorporated with the Q&A document for eCTD v4.0. See the eCTD v4.0 page.
Last updated: June 2021