ICH Project ICH E2D (R1) Guideline Workshops
April 10, 2024
The ICH E2D (R1) Expert Working Group (EWG) has been studying to revise the ICH E2D Guidelines. As a result, Step 2 was reached as of February 5, 2024 and published on the official ICH website. In Japan, a call for public comments on ICH E2D (R1) "Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports" (draft) was also launched on April 1, 2024.
We have decided to hold an ICH E2D (R1) Draft Guideline Workshops in order to promote understanding of the draft guideline and to support the collection of public comments.
The program and other details of the briefing can be found on the PMDA website.