Overview of comments received on ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver (EMA/CHMP/ICH/85092/2025)

Human medicines European public assessment report (EPAR): Hetronifly, serplulimab, Date of authorisation: 03/02/2025, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Tezspire, tezepelumab, Date of authorisation: 19/09/2022, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Date of authorisation: 13/02/2017, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Ifinwil, eflornithine, Status: Application withdrawn

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 07-09 July 2025

Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questions

European shortages monitoring platform (ESMP): updates and question and answer (Q&A) clinic for marketing authorisation holders (MAHs), Online, European Medicines Agency, Amsterdam, the Netherlands, from 24 June 2025, 10:30 (CEST) to 24 June 2025, 12:00 (CEST)

European Union Member State Public Holidays Recorded in CTIS (year: 2026)

EU Medicines Assessment - Opportunities for expert involvement, Online, European Medicines Agency, Amsterdam, the Netherlands, from 9 July 2025, 15:00 (CEST) to 9 July 2025, 16:15 (CEST)