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USA: FDA Publishes Draft Guidance on CMC Changes to a Biologics License Application

Friday, December 22, 2017: The US Food and Drug Administration (FDA) has published draft guidance intended to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in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The draft guidance, which is based on a tiered-reporting system for specific changes, provides general and administrative information on reporting and evaluating changes and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The draft guidance includes information regarding the types of reporting changes, special considerations, a glossary of terms and an appendix on of examples of post-approval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.

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