ICH Project ICH M14 Draft Guideline Workshops
July 09, 2024
The ICH M14 Expert Working Group (EWG) has been studying to develop the ICH M14 Guideline. As a result, Step 2 was reached as of May 21, 2024 and published on the official ICH website. In Japan, a call for public comments on the "ICH M14: General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines (draft)" was launched on June 17, 2024.
In order to promote understanding of the draft guideline and to support the collection of public comments, we held an ICH M14 Draft Guideline Workshops.
The program and other details of the briefing can be found on the PMDA website.