ICH Project ICH M4Q(R2) "CTD - Guideline (Draft) on Procedures for Preparation of Quality Documentation" Guideline Workshops
September 10, 2025
The ICH M4Q(R2) Expert Working Group (EWG) has been studying to revise the "Guidelines for the Preparation of CTD-Quality Documentation". As a result, the draft revision reached Step 2 as of May 14, 2025 and was published on the official ICH website. On August 22, 2025, ICH M4Q(R2) "Draft Guideline for the Preparation of CTD-Quality Documentation" was opened for public comments in Japan.
In order to promote understanding of the draft guideline and to support the collection of public comments, ICH M4Q(R2) held a Guideline Workshops on the draft guideline.
The details of the briefing can be viewed on the PMDA website below.
The archived version of the meeting will be available until Friday, November 21, 2025.