Issue Date: May 20, 2021
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Draft
ICH Q12: Implementation Considerations for FDA-Regulated Products: Draft Guidance for Industry
The International Council for Harmonisation (ICH) guidance for industry Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its Annexes (ICH Q12, May 2021) provide a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. ICH Q12 includes regulatory tools and enablers with associated guiding principles that should enhance industry’s ability to manage postapproval changes and increase transparency between industry and regulatory authorities, supporting innovation and continual improvement. • The original notice announcing availability of the guidance • The new notice about the reopening of the comment period
Download the Guidance Document
