ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate realworld evidence, with a focus on effectiveness of medicines

New pilot programme to support orphan medical devices

European Shortages Monitoring Platform Essentials and Industry Reporting Requirements, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 June 2024, 10:00 (CEST) to 24 June 2024, 12:30 (CEST)

Policy 82: Union Product Database (UPD) Access Policy - Veterinary Medicinal Products

List of medicines currently in PRIME scheme

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 22-25 July 2024

Human medicines European public assessment report (EPAR): Vazkepa, icosapent ethyl, Date of authorisation: 26/03/2021, Revision: 7, Status: Authorised

Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 June 2024, 13:00 (CEST) to 19 June 2024, 18:00 (CEST)

Human medicines European public assessment report (EPAR): Durveqtix, fidanacogene elaparvovec, Date of authorisation: 24/07/2024, Status: Authorised

Orphan designation: Recombinant human ADAMTS-13 Treatment of thrombotic thrombocytopenic purpura, 03/12/2008 Positive