Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture

Recommendation

29/30 November 2023

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In June, the FDA published a "Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture".

This document addresses manufacturers of licensed Whole Blood and blood components intended for transfusion or for further manufacture, including Source Plasma. It is supposed to provide recommendations for assisting them in determining which reporting mechanism is appropriate for submission of changes to an approved biologics license application (BLA) in accordance with the requirements under Title 21 Code of Federal Regulations (CFR) 601.12. (21 CFR 601.12). It further includes recommendations in connection with the applicability and content of comparability protocols under 21 CFR 601.12(e) and labeling changes under 21 CFR 601.12(f).

Finally, this guidanc will supersede the guidance of the same title dated July 2001 (July 2001 Guidance) announced in the Federal Register of August 7, 2001 (66 FR 41247) (Ref. 1).

Under 21 CFR 601.12, manufacturers have to report each change in the product, production process, quality controls, equipment, facilities, responsible personnel or labeling established in the approved license application to FDA in one of the following categories of submissions:

• a supplement which must be approved before distribution of the product made using the change;
• a supplement submitted at least 30 days before distribution of the product made using the change; or
• as a change described in an Annual Report (AR).

The submission category depends on the potential for the change to have an adverse effect on the “identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product”.

For more details with regard to which submission and reporting category a change to an approved application has to be assigned to, please see the Guidance for Industry "Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture".