ICH Project Briefing on ICH Q12 "Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management"
December 8, 2021
The ICH Q12 Guideline moved to Step 4 in November Reiwa 2, and the domestic guideline is scheduled to be issued by the end of the year. In the hope that the purpose and content of this guideline will be widely publicized among stakeholders in the pharmaceutical industry and lead to its appropriate utilization, we have decided to hold ICH Q12 Guideline Workshops.
Details regarding the program and other information for this briefing session are available on the PMDA website.