CMC Changes for Biologics: FDA Offers Draft Guidance

The US Food and Drug Administration (FDA) on Thursday released draft guidance intended to help applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in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).

Based on a tiered-reporting system for specific changes, the 43-page draft provides applicants and manufacturers with general and administrative information on reporting and evaluating changes and recommendations for reporting categories.

When finalized, the guidance is intended to supersede the document: "Guidance for Industry: Changes to an Approved Application: Biological Products" from July 1997.

"We are updating the July 1997 guidance to accommodate advances in manufacturing and testing technology and to clarify the FDA’s current thinking on assessing reportable changes," FDA said in Thursday’s Federal Register. "The updated guidance applies to certain biological products licensed under the Public Health Service Act (PHS Act), including in vitro diagnostics licensed under BLAs," though it 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 features sections on 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.

Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products: Draft Guidance for Industry