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(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.
Established
May, 2015
Members
Office of New Drug I to V
Office of Cellular and Tissue-based Products
Office of Vaccines and Blood Products
Office of Generic Drugs
Office of Manufacturing Quality for Drugs
Office of Regulatory Science Coordination
Past Presentation (Related to PMDA-sponsored/co-sponsored workshop)
- ICH Q12「TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT」PMDA-JPMA session
Joint JPMA/MHLW-PMDA session, Web, December 2021
Past Presentations
- ICH Q12「TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT」DRAFT PMDA-JPMA session
Osaka and Tokyo, Japan, March 2018