ICH Project ICH Q9 (R1) Guideline Workshops
October 12, 2023
The ICH Q9(R1) Expert Working Group (EWG) has been studying to develop guidelines for quality risk management.
As a result, the draft ICH Q9(R1) Guideline reached Step 4 as of January 18, 2023, and was published on the official ICH website and issued as a notice by the Ministry of Health, Labour and Welfare in Japan on August 31, 2023. We held the ICH Q9(R1) Guideline Workshops in the hope that the purpose and contents of this guideline will be widely known to the pharmaceutical industry and that the guideline will be appropriately utilized.
The details of the briefing, including the program, are available on the PMDA Website.