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)

First European Medicines Agency (EMA) and Active Pharmaceutical Ingredients Committee (APIC) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 2 September 2026, 15:30 (CEST) to 2 September 2026, 17:30 (CEST)

Human medicines European public assessment report (EPAR): Kaftrio, ivacaftor,tezacaftor,elexacaftor, Date of authorisation: 21/08/2020, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR): Multaq, dronedarone, Date of authorisation: 25/11/2009, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Aspaveli, pegcetacoplan, Date of authorisation: 13/12/2021, Revision: 14, Status: Authorised

Medicines for human use under evaluation

Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (26 June 2026 - 23 July 2026)

Start of procedure: Extension of marketing authorisation (26 June 2026 - 23 July 2026)

New leadership team appointments

Dates of 2027 SAWP meetings and submission deadlines Scientific advice, protocol assistance, qualification of biomarkers and parallel HTACG/EMA Joint Scientific Consultation requests