ICH Project ICH M4Q (R2) “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (Draft)” Briefing Session
September 10, 2025
The ICH M4Q (R2) Expert Working Group (EWG) has been continuing its deliberations toward revising the “Guideline on the Preparation of Quality-Related Documentation (CTD).” As a result, the draft revision reached Step 2 on May 14, 2025, and was published on the official ICH website.In Japan as well, the call for public comments on the ICH M4Q (R2) “Guideline on the Preparation of Quality-Related Documentation (Draft)” began on August 22, 2025.
To promote understanding of the draft guidelines and support the collection of public comments, we recently held Guideline Workshops on the draft ICH M4Q (R2) guidelines.
Details regarding the briefing session can be found on the PMDA website at the following link:
Please note that the archived recording of the briefing session will be available for viewing until Friday, November 21, 2025.