Sponsor guidance: New safety module on the annual safety report

Enpr-EMA priority activities

18th Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 September 2026, 09:00 (CEST) to 21 September 2026, 12:30 (CEST)

Human medicines European public assessment report (EPAR): Susvimo, ranibizumab, Date of authorisation: 18/09/2026, Status: Authorised

Human medicines European public assessment report (EPAR): Pregabalin Viatris Pharma (previously Pregabalin Pfizer), pregabalin, Date of authorisation: 10/04/2014, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR): Tevimbra, tislelizumab, Date of authorisation: 15/09/2023, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Cometriq, cabozantinib, Date of authorisation: 21/03/2014, Revision: 33, Status: Authorised

PDCO minutes of the 21-24 July 2026 meeting

Regulatory perspectives on herbal medicinal / botanical drug product development: Joint FDA / EMA workshop, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 25 September 2026, 10:00 (CEST) to 25 September 2026, 13:00 (CEST)

Member states contact points for review of national implementation of quick response (QR) codes of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures