日本生物制药的法规更新和前景.pdf

1、Copyright Pharmaceuticals and Medical Devices Agency,All Rights Reserved.Regulatory Updates and a Perspective on Biopharmaceuticals in JapanSAKURAI Akira,Ph.D.Senior Scientist for Biopharmaceutical Quality Center for Product Evaluation Pharmaceuticals and Medical Devices Agency(PMDA),JapanCopyright

2、Pharmaceuticals and Medical Devices Agency,All Rights Reserved.1doi:https:/doi.org/10.1038/d41573-024-00153-wIce BreakerIce BreakerCopyright Pharmaceuticals and Medical Devices Agency,All Rights Reserved.AgendaAgenda Regulatory Update in Japan Post-approval Change for Moderate risk(trial)Partial App

3、roval Change with a period of suspension Science Board Microbiome EV products in vivo gene therapy products with Target Specificity InformationCopyright Pharmaceuticals and Medical Devices Agency,All Rights Reserved.AgendaAgenda Regulatory Update in Japan Post-approval Change for Moderate risk(trial

4、)Partial Approval Change with a period of suspension Science Board Microbiome EV products in vivo gene therapy products with Target Specificity InformationCopyright Pharmaceuticals and Medical Devices Agency,All Rights Reserved.4Recent MHLWs Initiatives9.Jun,2023Report of the Panel of Experts on Com

5、prehensive Measures to AchieveRapid and Stable Supply of Pharmaceuticalshttps:/www.mhlw.go.jp/stf/newpage_33548.html Ensure stable supply Strengthen drug discovery capabilities Resolve the issues of“drug lag/loss”Efforts toward appropriate distribution of pharmaceuticals10.Jul,2023Review Committee o

6、n Pharmaceutical Regulation for Strengthening Drug Discovery Capabilities and Securing Stable Supplyhttps:/www.mhlw.go.jp/stf/shingi/other-iyaku_128701_00006.html(MHLW;Minister of Health Labour and Welfare)Copyright Pharmaceuticals and Medical Devices Agency,All Rights Reserved.5Review Committee on