ICH Project Briefing on ICH Q12 "Guidelines for Technical and Regulatory Approaches to Drug Lifecycle Management

Dec 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 a briefing session on ICH Q12 Guideline in the hope that the purpose and contents of this guideline will be widely known to those involved in the pharmaceutical industry, leading to appropriate use of the guideline.

The program and other details of the briefing can be found on the PMDA Website.

PMDA Website

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