The European Union (EU) has taken a major step towards ushering in new rules that will safeguard the supply of critical medicines and help avoid shortages, reflecting the latest step by the region to bolster its pharma ecosystem amid international pressures.
The European Parliament and Council have reached an agreement to advance the Critical Medicines Act (CMA), a framework first proposed in March 2025. The regulation aims to strengthen the resilience and security of critical medicine supplies for patients across Europe.
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Objectives include bolstering manufacturing capacities for critical medicines, lowering the risk for supply chain disruptions, leveraging collaborative procurement procedures, and diversifying supply chains via strategic partnerships.
According to the European Parliament, the new rules – which are still to be formally adopted as legislation – will reduce dependency on non-EU countries and boost the competitiveness of its pharmaceutical industry. In 2025, imports of medicinal and pharmaceutical products grew 21%, while exports increased by 16%. The US is the EU’s main partner for imports.
Medicines such as antibiotics, vaccines, and products for chronic and rare diseases stand to benefit from the new framework. There are around 300 medicines on the Union’s 2026 list of critical medicines. These range from common treatments such as paracetamol and insulin, to less frequently prescribed immunosuppressants and antibacterials, for example. The list contains medicines whose continued supply is deemed a priority for public health.
European Parliament member, Tomislav Sokol, who presented the deal, said: “By introducing collaborative procurement at EU level, we are taking concrete action to address shortages and ensure security of supply.
“At the same time, we are sending a clear signal that Europe is committed to strengthening its pharmaceutical manufacturing base. Companies that produce medicines in Europe will be favoured in procurement procedures. Strategic projects will benefit from access to national and EU funding and from faster and more efficient permitting procedures.”
The European Medicines Agency (EMA) welcomed the agreement on the proposed CMA. The agency highlighted the Covid-19 pandemic and geopolitical tensions as factors that can uncover weaknesses in pharmaceutical supply chains.
The latter is especially pertinent now given the ongoing conflict in the Middle East. Commercial activity through the Strait of Hormuz – a critical maritime chokepoint – remains 90% below pre-war levels.
EMA’s Executive Director, Emer Cooke, commented: “At a time of increasing global disruptions, resilient and secure supply chains for critical medicines are essential to protect public health across the EU.
“Today’s provisional agreement on the Critical Medicines Act marks a significant milestone towards strengthening Europe’s capacity to improve the availability, supply and production of critical medicines.”
