ICH Project ICH E2D (R1) Draft Guideline Briefing
Apr 10, 2024
The ICH E2D (R1) Expert Working Group (EWG) has been studying the revision of 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 information: Definitions and criteria for handling and reporting individual case safety reports" (draft) was also launched on April 1, 2024.
In order to promote understanding of the draft guideline and to support the collection of public comments, we have decided to hold an explanatory meeting on the ICH E2D (R1) draft guideline.
The program and other details of the briefing can be found on the PMDA Website.
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