ICH Project ICH Q9 (R1) Guideline Workshops
October 12, 2023
The ICH Q9 (R1) Expert Working Group (EWG) has been continuing its deliberations toward the development of guidelines on quality risk management.
As a result, on January 18, 2023, the draft ICH Q9 (R1) guideline reached Step 4 and was published on the official ICH website; in Japan, it was also issued as a notification by the Ministry of Health, Labor and Welfare on August 31, 2023.We held ICH Q9 (R1) Guideline Workshops in the hope that the purpose and content of this guideline would be widely publicized among stakeholders in the pharmaceutical industry, leading to its appropriate utilization.
Details regarding the program and other information for this briefing session are available on the PMDA website.