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# Implementing ICH Q12 Postapproval Changes
- URL: https://www.fdaweb.com/implementing-ich-q12-postapproval-changes/
- Published: 2021-05-21T12:00:00.000Z
- Updated: 2026-09-14T16:59:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149375

*Federal Register* notice: FDA has made available a draft guidance *entitled ICH Q12: Implementation Considerations for FDA-Regulated Products*. The document helps U.S.-regulated firms implement an International Council for Harmonization guidance entitled *Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management* and its annexes. It also 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. To view the document, click [here](https://www.govinfo.gov/content/pkg/FR-2021-05-20/pdf/2021-10611.pdf?ref=fdaweb.com).