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)

Signal management

Questions and answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by marketing authorisation holders

Development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making - Scientific guideline

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group

Demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Scientific guideline

Orphan designation: Humanised IgG1 monoclonal antibody against adrenocorticotropic hormone Treatment of congenital adrenal hyperplasia, 20/06/2025 Positive