ICH Project ICH E2D (R1) Draft Guideline Workshops
April 10, 2024
The ICH E2D (R1) Expert Working Group (EWG) has been continuing its deliberations toward revising the ICH E2D guideline. As a result, the draft reached Step 2 on February 5, 2024, and was published on the official ICH website.In Japan as well, the call for public comments on the draft ICH E2D (R1) “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” began on April 1, 2024.
To promote understanding of this draft guideline and to support the collection of public comments, we have decided to hold Guideline Workshops on the draft ICH E2D (R1) guideline.
Details regarding the program and other information for this briefing session are available on the PMDA website.