A View on the EU Critical Medicines Act to secure Pharma Supply Chains

CMO Oversight - Quality Oversight of Pharmaceutical Contract Manufacturing Organisations

Recommendation

10/11 December 2025
Berlin, Germany

CMO Oversight - Quality Oversight of Pharmaceutical Contract Manufacturing Organisations
What MAHs and Virtual Companies need to know

An article from Bird & Bird, titled "Europe's medicine supply crisis: How the EU's bold new act aims to address supply chain vulnerabilities," discusses the European Union's proposed Critical Medicines Act (CMA), introduced in March 2025. This legislative initiative aims to tackle persistent medicine shortages and reduce the EU's reliance on non-EU countries for pharmaceutical production.

The EU has faced ongoing medicine shortages, exacerbated by the COVID-19 pandemic and geopolitical tensions. These issues have highlighted the risks of dependency on third-country manufacturing, particularly for critical medicines.

The article describes in a comprehensive way background, scope and key elements of the CMA and emphasizes that the CMA represents a significant shift in EU pharmaceutical policy, moving beyond regulatory measures to include industrial policy tools aimed at ensuring medicine availability and supply chain resilience.

For a more detailed analysis, you can read the full article here.