ICH Project ICH S12: Briefing on the draft guideline "Approach for Nonclinical Biodistribution Considerations for Gene Therapy Products" (draft) that reached Step 2
July 29, 2021
ICH S12 "Concept of Non-clinical Biodistribution Considerations for Gene Therapy Products" has reached Step 2, and a briefing session was held jointly by Japan Pharmaceutical Manufacturers Association, Ministry of Health, Labour and Welfare, and Pharmaceuticals and Medical Devices Agency (PMDA).