On January 11, 2026, the U.S. Food and Drug Administration (FDA) announced flexible Chemistry, Manufacturing, and Control (CMC) requirements for cell and gene therapies (CGT) to expedite product development and guide Biologics License Application (BLA) preparation. These flexibilities cover clinical development, commercial specifications, and process validation.
For clinical development, the manufacturer will not required to comply with 21 CFR Part 211 prior to Phase 2 or Phase 3 trials. For commercial specifications, the FDA allows flexible product release specifications for BLAs and permits post‑approval re‑evaluation of release criteria. For process validation, certain Process Performance Qualification (PPQ) lots may be released concurrently, and three PPQ lots are not mandatory. The FDA encourages sponsors to consult review divisions on CMC‑related questions during product development.
Source | https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/flexible-requirements-cell-and-gene-therapies-advance-innovation
- PDF Version