ICH Project Briefing on ICH E6 (R3) "Guideline for Good Clinical Practice (Draft)"
July 31, 2023
The ICH E6(R3) Expert Working Group (EWG) has been continuing its deliberations toward revising the Guideline for Good Clinical Practice for pharmaceutical products.As a result, on May 19, 2023, the “Principles” and “Annex 1” sections of the draft ICH E6 (R3) guideline reached Step 2 and were published on the official ICH website.In Japan as well, the call for public comments on the draft ICH E6 (R3) “Good Clinical Practice for Medicinal Products” began on July 10, 2023.
To promote understanding of this draft guideline and support the collection of public comments, we recently held Guideline Workshops on the draft ICH E6 (R3) guideline.
Details regarding the program and other information for this briefing session are available on the PMDA website.