ICH Project ICH M14 Draft Guideline Workshops
July 9, 2024
The ICH M14 Expert Working Group (EWG) has been continuing its deliberations toward the development of the ICH M14 guideline. As a result, the draft reached Step 2 on May 21, 2024, and was published on the official ICH website.In Japan as well, the call for public comments on “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)” began on June 17, 2024.
To promote understanding of this draft guideline and support the collection of public comments, we recently held Guideline Workshops on the draft ICH M14 guideline
. Details regarding the program and other information for these Guideline Workshops are available on the PMDA website.