12 May 2026

The European Medicines Agency (EMA) has welcomed the provisional agreement by the European Parliament and Council of the EU on the Critical Medicines Act (CMA), marking a significant step towards strengthening the resilience and security of medicine supply chains across the EU. The Act combines regulatory tools with industrial policy measures to reinforce manufacturing capacity and improve access to critical medicines, including those for rare diseases, responding to vulnerabilities exposed by the COVID-19 pandemic, geopolitical tensions and recurring shortages in recent years. In preparation for its implementation, EMA is already advancing supply chain vulnerability assessments for medicines on the Union list of critical medicines and expanding the European Shortages Monitoring Platform.

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