Overview
The legislative file 2023/0131(COD) concerns a comprehensive reform of the European Union's framework for authorising and supervising medicinal products for human use and the rules governing the European Medicines Agency (EMA). The procedure is ongoing under the ordinary legislative procedure. The analysis is based on the Council document (ST 6366 2026 INIT), which presents the final compromise text intended to replace Regulation (EC) No 726/2004. This reform aims to reshape the EU pharmaceutical landscape by addressing authorisation procedures, supply security, and patient access, drawing on objectives from the EU's Pharmaceutical Strategy.
Legislative timeline
The file was referred to the European Parliament for a first reading on 14 September 2023. The committee report was tabled on 20 October 2023, followed by the tabling of committee opinions and numerous amendments throughout November 2023. Committee opinions were adopted in January and February 2024. Interinstitutional negotiations between the Parliament and the Council commenced in 2025, with sessions held on 17 June, 7 October, and 11 November 2025. A Council meeting is scheduled for 3 June 2026 concerning the regulation.
Institutional handling
The European Commission's lead department is the Directorate-General for Health and Food Safety (SANTE), under the responsibility of Commissioner Olivér Várhelyi. In the European Parliament, the file is being handled by the responsible committee, which has tabled a report and amendments. In the Council of the EU, the dossier is managed by the Environment Council (ENV) configuration.
Stakeholder reactions
Stakeholder engagement on this file has been extensive, with 72 documented meetings held between stakeholders and EU policymakers. Of these, 53 meetings were with Members of the European Parliament, and 19 were with European Commission staff. The outreach involved 50 distinct organisations. The most frequently engaged organisations include the European Federation of Pharmaceutical Industries and Associations, F. Hoffmann-La Roche Ltd, ILGA-Europe, Eli Lilly and Company, and GSK. While the provided stakeholder position data references topics like the Carbon Border Adjustment Mechanism and regulatory simplification from other engagements, it does not specify positions directly related to the provisions of this pharmaceutical regulation.
Media coverage
No data on media coverage is provided.