Antivirals cluster – Terms of Reference

Terms of reference for biosimilars cluster

Terms of reference for the advanced therapy medicinal products cluster

Human medicines European public assessment report (EPAR): Kefdensis, denosumab, Date of authorisation: 17/11/2025, Revision: 3, Status: Authorised

Guiding principles for the EMA - US FDA cluster teleconferences on Artificial Intelligence in Pharmacovigilance

Human medicines European public assessment report (EPAR): Hukyndra, adalimumab, Date of authorisation: 15/11/2021, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Flucelvax, influenza vaccine (surface antigen, inactivated, prepared in cell cultures), Date of authorisation: 15/11/2024, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Fluad, influenza vaccine (surface antigen, inactivated, adjuvanted), Date of authorisation: 15/11/2024, Revision: 2, Status: Authorised

Advice on the influenza virus on request from the Medical Device Coordination Group

Minutes of the HMPC meeting 4-6 May 2026