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(Note).
(Note) 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.
（Activity period:：From May, 2015 to September, 2024）
Activities
The activities conducted over the last five years.
Symposiums
- ICH Q12「TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT」PMDA-JPMA session
Joint JPMA/MHLW-PMDA session, Web, December 2021