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 working on the revision of the ICH E6(R3) (Guideline for Good Clinical Practice) Guidelines for Clinical Trials on Medicinal Products. As a result, as of May 19, 2023, Principles and Annex 1 of the draft ICH E6(R3) Guidelines reached Step 2 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 this draft guideline and to support the collection of public comments, we recently held an ICH E6(R3) Draft Guideline Workshops.
The program and other details of the briefing can be found on the PMDA website.