Consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets - Scientific guideline

This concept paper addresses the need for a guideline on evaluation of consumer safety of biological active substances of immunological veterinary medicinal products (IVMPs) intended to produce active immunity, e.g. antibodies, against endogenous targets, e.g., cytokines, in food-producing species. Similar endogenous targets may be present in the body of the consumer that could be aimed at upon ingestion of foodstuff from treated animals containing residues of the active substance of the IVMP or its effectors (e.g. antibodies). Although the risk to the consumer is likely to be very low, it needs to be considered as part of the safety evaluation.

Keywords: Consumer safety, immunologicals, endogenous targets

Current version

Concept paper on the development of a guideline on consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets

Draft: consultation openConsultation dates: 23/05/2025 to 31/08/2025Reference Number: EMA/CVMP/SWP/564861/2023Summary:

Comments should be provided using this template. The completed comments form should be sent to [e-mail]