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About this WG

ICH Q12 WG is a multi-sectional working group (WG) within PMDA.
The purpose of ICH Q12 WG is to discuss regulatory issues related to ICH Q12*.

*ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle) is one of the quality guidelines which is being discussed in the International Council for Harmonisation (ICH).
ICH Q12 is proposed to provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more  predictable  and efficient manner across the product lifecycle.


May, 2015


Office of New Drug I-V 
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Generic Drugs
Office of Manufacturing/Quality and Compliance
Office of Research Promotion

Past Presentations

Date Presentation Title Place
Dec. 2017 How Will ICH Q12 Fly in Japan? CMC Strategy Forum Japan 2017, Tokyo, Japan
Nov. 2017 ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective 14th Annual Meeting, DIA Japan
2017, Tokyo, Japan
Dec. 2016

Connection from ICH Q12 (ECs) to
Application Form (Approved Matters)


PMDA Perspective on Established
Conditions for Specification -in connection with Japanese Application Form-

Established Conditions for manufacturing
process –PMDA perspective

CMC Strategy Forum Japan 2016, Tokyo, Japan
Nov. 2016

ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective

13th Annual Meeting, DIA Japan
2016, Tokyo, Japan

Jul. 2016

Post-Approval CMC Changes in Japan: How We Envision the Future

CMC Strategy Forum Summer
2016, Gaithersburg, USA

Apr. 2016

ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective

ISPE Japan Affiliate 2016 Annual Meeting, Tokyo, Japan

Nov. 2015

ICH Q12 (Pharmaceutical Product Lifecycle Management): Current Status and Future Perspectives

CMC Strategy Forum Japan 2015, Tokyo, Japan


JCN 3010005007409

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