ICH Project ICH Q12 "Guidelines for Technical and Regulatory Approaches to Drug Lifecycle Management" Guideline Workshops
December 08, 2021
The ICH Q12 Guideline moved to Step 4 in November 2020, and the domestic guideline is scheduled to be issued within this year. We have decided to hold ICH Q12 Guideline Workshops in the hope that the purpose and contents of this guideline will be widely known to the pharmaceutical industry and that this will lead to appropriate utilization of the guideline.
The program and other details of the briefing can be found on the PMDA Website.