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# Guide on Reporting CMC Changes for BLAs
- URL: https://www.fdaweb.com/guide-on-reporting-cmc-changes-for-blas/
- Published: 2021-06-21T12:00:00.000Z
- Updated: 2026-09-14T17:04:12.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149577

FDA has released a [final ](https://www.fda.gov/media/109615/download?ref=fdaweb.com)[guidance ](https://www.fda.gov/media/109615/download?ref=fdaweb.com)entitled *Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products*. The document is intended to help biologic manufacturers/sponsors in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls information to an approved BLA. It describes general and administrative information on evaluating and reporting changes and recommendations for reporting categories based on a tiered-reporting system for specific changes under 21 CFR 601.12.