ICH M4Q（R2） 更新.pdf

1、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 opi

2、nions expressed in this presentation are those of the presenter and should not necessarily represent the views and opinions of the PMDA or ICH M4Q(R2)EWG.Updates on ICH M4Q(R2)Copyright Pharmaceuticals and Medical Devices Agency,All Rights Reserved.1Outline Background&M4Q(R2)objectives Current EWG t

3、hinking 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)publish

4、ed in 2002 was a substantial improvement compared to the prior state with range of submission formats and shift from paper to electronic2Copyright Pharmaceuticals and Medical Devices Agency,All Rights Reserved.ICH M4Q(R2)Concept Paper 3ICH_M4Q-R2_ConceptPaper_Endorsed_2021_1115.pdfCopyright Pharmace

5、uticals and Medical Devices Agency,All Rights Reserved.What are the Issues to be Resolved?4Organizing product and manufacturing information in a suitable format for easy access,analysis,and knowledge management.Better capturing the pharmaceutical development and the proposed overall control strategy

6、,which should be the backbone of the revised M4Q structure.Establishing the role of M4Q(R2)as the main source of the structure and location of regulatory quality information.Enhancing the Quality Module 2 to facilitate the efficiency and effectiveness of regulatory submissions and assessments.Incorp