FDA publishes draft guidance on CMC changes to a biologics license application

The US Food and Drug Administration (FDA) has published draft guidance intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA).

The draft guidance, which is based on a tiered-reporting system for specific changes, provides general and administrative information on reporting and evaluating changes and recommendations for reporting categories. The guidance is intended to replace the document: “Guidance for Industry: Changes to an Approved Application: Biological Products” from July 1972 when finalised.

Licensed biological products that fall within the scope of this guidance include: vaccines, allergenic products, plasma-derived products, antitoxins, antivenins, naturally-derived protein products, cell-based gene therapy products and in vitro diagnostics regulated under the Public Health Service Act. The guidance does not apply to: human cells, tissues, and cellular and tissue-based products; specified biotechnology and specified synthetic biological products; and biosimilar biological products subject to licensure under section 351(k) of the PHS Act.

The draft guidance includes information regarding the types of reporting changes, special considerations, a glossary of terms and an appendix on of examples of post-approval manufacturing changes and recommended reporting categories.

To view the FDA draft guidance on CMC changes to an approved application for certain biologics, please click here.