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# FDA Issues Drug Product Lifecycle ICH Guidance
- URL: https://www.fdaweb.com/fda-issues-drug-product-lifecycle-ich-guidance/
- Published: 2018-05-30T12:00:00.000Z
- Updated: 2026-09-15T00:09:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141559

FDA has published an International Conference on Harmonization draft guidance, *Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management*, that “provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner.” The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609205.pdf?ref=fdaweb.com) also is intended to demonstrate how increased product and process knowledge can contribute to a reduction in the number of regulatory submissions. “Effective implementation of the tools and enablers described in this guidance should enhance industry’s ability to manage many CMC changes effectively under the firm’s pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation,” it says.