ICHM4QR2更新

Copyright © Pharmaceuticals and Medical Devices Agency, All Rights Reserved.CMC Strategy Forum Japan 2024, 9-10 December, 2024, Tokyo Marriot Hotel, Tokyo, JapanKISHIOKA Yasuhiro, Ph.D.Review DirectorOffice of Cellular and Tissue-based ProductsPharmaceuticals and Medical Devices Agency (PMDA)The views and opinions expressed in this presentation are those of the presenterand should not necessarily represent the views and opinions of the PMDAorICHM4Q(R2)EWG.Updates on ICH M4Q(R2)Copyright © Pharmaceuticals and Medical Devices Agency, All Rights Reserved.1Outline◼Background & M4Q(R2) objectives◼Current EWG thinking◼Future Plan Copyright © Pharmaceuticals and Medical Devices Agency, All Rights Reserved.ICH Quality Submission: M4Q(R1) ◼Globally harmonized content and organization of quality information in Common Technical Document (CTD)/eCTD◼Module 2.3 Quality Overall Summary (QOS)◼Module 3 Quality◼M4Q(R1) published in 2002 was a substantial improvement