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# ICH Q12 Technical, Regulatory Consideration Annex
- URL: https://www.fdaweb.com/ich-q12-technical-regulatory-consideration-annex/
- Published: 2021-05-11T12:00:00.000Z
- Updated: 2026-09-14T16:58:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149287

FDA has published a guidance, *Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: Annexes*, providing a framework to facilitate the management of postapproval chemistry, manufacturing, and controls changes more predictably and efficiently. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q12-technical-and-regulatory-considerations-pharmaceutical-product-lifecycle-management-annex?ref=fdaweb.com), approved by the International Council for Harmonization, discusses how to identify the elements in an application that are considered necessary to assure product quality and therefore would require a regulatory submission if changed postapproval. FDA also says the guidance has the potential to help facilitate innovation in manufacturing through a flexible, risk-based approach to regulatory oversight.