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# ICH Guide on Q12 Post-approval Drug Changes
- URL: https://www.fdaweb.com/ich-guide-on-q12-post-approval-drug-changes/
- Published: 2018-05-31T12:00:00.000Z
- Updated: 2026-09-15T00:09:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141571

*Federal Register* notice: FDA has made available a guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonization.” The document provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including marketed chemical and biotechnological/biological products. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-05-31/pdf/2018-11641.pdf?ref=fdaweb.com).