Annual report of the Good Clinical Practice Inspectors Working Group 2024

Human medicines European public assessment report (EPAR): Aflunov, zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), Date of authorisation: 28/11/2010, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Daptomycin Hospira, daptomycin, Date of authorisation: 22/03/2017, Revision: 16, Status: Authorised

Data access to medicinal products for human use - Chapter 5

Human medicines European public assessment report (EPAR): Tocilizumab STADA (previously Tofidence), tocilizumab, Date of authorisation: 20/06/2024, Revision: 4, Status: Authorised

Standard operating procedure for procedure to be followed when the incident management plan for medicines for veterinary use is triggered

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

New product information wording: extracts from PRAC recommendations on signals adopted at the 27-30 October 2025 PRAC

Fourth European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 8 December 2025, 13:00 (CET) to 8 December 2025, 15:00 (CET)

Applications for new human medicines under evaluation: January 2026