European Commission and Directorate-General for Health and Food Safety 11 March 2025, Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

Also known as

The proposed Regulation aims to enhance the availability and security of supply for critical medicinal products within the EU, addressing vulnerabilities in pharmaceutical supply chains exacerbated by recent global events. Key provisions include the establishment of a Union List of Critical Medicines, measures to incentivize manufacturing investments, and collaborative procurement strategies to ensure equitable access across Member States. The Regulation aligns with existing EU health policies and aims to bolster economic security by reducing dependencies on non-EU sources for essential medicines.AI