ICH Project ICH S12: Briefing on the draft guideline "Approach for Non-clinical Biodistribution Studies of Gene Therapy Products" (draft) that reached Step 2

Jul 29, 2021

ICH S12 "Concept of Non-clinical Biodistribution Studies for Gene Therapy Products" has reached Step 2, and a briefing session was held jointly by the Japan Pharmaceutical Manufacturers Association (JPMA), the Ministry of Health, Labour and Welfare (MHLW), and the Pharmaceuticals and Medical Devices Agency (PMDA).

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