The US Food and Drug Administration (FDA) has published draft guidance intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in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The draft guidance, which is based on a tiered-reporting system for specific changes, provides general and administrative information on reporting and evaluating changes and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The draft guidance includes information regarding the types of reporting changes, special considerations, a glossary of terms and an appendix on of examples of post-approval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To view the FDA draft guidance on CMC changes to an approved application for certain biologics, please click here.