ICH Project ICH E6(R3) "Criteria for Conducting Clinical Studies of Pharmaceuticals" Guideline Workshops
July 31, 2023
The ICH E6(R3) (Guideline for Good Clinical Practice) Expert Working Group (EWG) has been studying the draft guideline for Good Clinical Practice for pharmaceutical products. As a result, as of May 19, 2023, Principles and Annex 1 of the draft ICH E6(R3) Guidelines have reached Step 2 and have been 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 this draft guideline and to support the collection of public comments, we have recently held an ICH E6(R3) Draft Guideline Workshops.
The program and other details of the briefing can be found on the PMDA website.