EU Advances Major Reform of Pharmaceutical Legislation

The Committee of Permanent Representatives of the European Union (COREPER I) has approved the trilogue agreement reached in December 2025 on a major overhaul of the EU’s pharmaceutical framework. The final texts for a new directive and regulation governing medicinal products for human use have now been officially published.

The proposed directive will replace Directive 2001/83/EC, while the new regulation will update EU procedures for authorising and supervising medicines and revise the framework governing the European Medicines Agency. It will also amend existing regulations related to advanced therapies and clinical trials.

The European Parliament’s Committee on Public Health is scheduled to vote on the texts on 18 March 2026. After approval, the legislation will undergo translation into all EU languages before publication in the Official Journal and formal entry into force.

The reform represents the most significant update to EU pharmaceutical legislation in more than two decades, aiming to modernise the development, approval and supply of medicines across the European Union.

09-03-2026