Removal Of ‘Legal’ And ‘Implicit’ Terms Cleared Way For ICH Q12 Guideline

11 Jan 2020

• By Joanne S. Eglovitch

Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.

Businessman sinking in heap of documents and asking for help — ICH Q12 Should Ease Postapproval Reporting Burden • Source: Shutterstock

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...