ICH Project ICH E6(R3) "Standards for the Conduct of Clinical Studies of Pharmaceuticals" Draft Guideline Briefing Session
Jul 31, 2023
The ICH E6(R3) Expert Working Group (EWG) has continued to study the revision of the guideline on the Standards of Practice for Clinical Trials of Pharmaceuticals. As a result, Principles and Annex 1 of the draft ICH E6(R3) Guidelines reached Step 2 as of May 19, 2023, and were published on the official ICH website. In Japan, the call for public comments on the ICH E6(R3) "Draft Standard for Conducting Clinical Studies on Pharmaceutical Products" was launched on July 10, 2023.
In order to promote understanding of the draft guideline and to support the collection of public comments, an explanatory meeting on the ICH E6(R3) draft guideline was held this time.
The program and other details of the briefing can be found on the PMDA Website.
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