FDA Publishes Guidance on CMC Changes to an Approved Application

FDA issued final guidance on June 21, 2021 to help 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). The guidance document includes general and administration information for evaluating and reporting changes and reporting categories based on a tiered-reporting system. The final guidance supersedes the July 1997 guidance, Guidance for Industry: Changes to an Approved Application: Biological Products.

Specifically, 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 FDA is also discussed. The document also provides the requirements for submitting changes to the agency and recommendations for reporting categories. Special considerations discussed in the document include process parameter changes and changes in raw materials suppliers.