The final version of an internationally harmonized guideline on postapproval manufacturing changes lacks any mention of the regional legal concerns raised in the draft version that industry complained would have set a bad precedent, and removes ambiguity by eliminating a distinction between implicit and explicit conditions of regulatory approval.
Through these revisions, the International Council on Harmonisation addressed complaints from industry that the draft version of its Q12 post-approval changes guidance lacked a global framework for core concepts like established conditions (ECs) and product lifecycle management (PLCM), while also addressing industry concerns that more clarity was needed on explicit versus implicit established conditions
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?