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# Guidance on CMC Flexibility for Human CGTs
- URL: https://www.fdaweb.com/guidance-on-cmc-flexibility-for-human-cgts/
- Published: 2026-05-06T12:00:00.000Z
- Updated: 2026-09-14T13:38:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161103

FDA has published a guidance, *Chemistry, Manufacturing, and Controls Flexibilities for Developing a Human Cellular and Gene Therapy Product for a Biologics License Application*, describing how the agency applies flexibility to the chemistry, manufacturing, and controls (CMC) requirements for human cellular and gene therapy (CGT) products being developed for BLAs. The [document](https://www.fda.gov/media/192321/download?ref=fdaweb.com) says the agency uses a flexible approach to ensuring applicable CMC requirements are met for CGT products.

“FDA’s flexible approach serves to help expedite development, review, and patient access to safe and effective CGT products to treat serious or life-threatening conditions that represent significant unmet medical needs,” the guidance says.

The guidance applies only to CGT products regulated by CBER and does not apply to animal CGT products regulated by the Center for Veterinary Medicine or to other biological products.

FDA says sponsors should discuss their approach for CMC development with the relevant review division before implementation.