Guidance on CMC Changes to an Approved Application- US-FDA

FDA issued final guidance on June 21, 2021 to aid applicants of certain licensed biological products to determine the appropriate reporting category for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA).

This guidance finalizes the draft guidance, “Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products” dated December 2017, and supersedes the guidance entitled “Guidance for Industry: Changes to an Approved Application: Biological Products” dated 1997 (July 1997 guidance).

The guidance details reporting categories such as Prior Approval Supplement (PAS), Changes Being Effected in 30 Days/Changes Being Effected Supplements (CBE30/CBE), and Annual Report.

The assessment of a change by the applicant and by the FDA is also discussed. The document also provides the requirements for submitting changes to the agency and recommendations for reporting categories.