Applications for new human medicines under evaluation: October 2025

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 22-24 September 2025

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 October 2025

European Medicines Agency (EMA) and European Respiratory Society (ERS) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 October 2025, 13:00 (CET) to 30 October 2025, 15:00 (CET)

ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines - Scientific guideline

ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5

Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

Veterinary medicines European public assessment report (EPAR): Novem, meloxicam, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Oncept IL-2, feline interleukin-2 recombinant canarypox virus (vCP1338 virus), Status: Authorised

Veterinary medicines European public assessment report (EPAR): Osurnia, terbinafine,florfenicol,betamethasone, Status: Authorised