EMA welcomes political agreement on Critical Medicines Act
Act to improve availability, production and supply of critical medicines in the European Union
NewsHumanMedicine shortagesMedicines
EMA welcomes the provisional agreement reached by the European Parliament and the Council of the European Union on the proposed Critical Medicines Act (CMA), which represents an important step in strengthening the resilience, security and sustainability of the European Union’s supply of critical medicines.
“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.”
In recent years, EU Member States have faced serious medicine shortages and global challenges such as the COVID-19 pandemic and geopolitical tensions have exposed vulnerabilities in the pharmaceutical supply chain. Shortages of medicines can put patients' lives at risk and place a significant burden on healthcare systems. They may arise from reasons including manufacturing issues, supply chain vulnerabilities or global competition for resources.
By combining regulatory tools with targeted industrial policy measures, the CMA strengthens preparedness and supports a more resilient supply of medicines for patients. It builds on the regulatory tools introduced through EMA’s extended mandate and complements the measures in the revised EU pharmaceutical legislation, to reinforce manufacturing capacity and supply resilience for critical medicines. It also aims to improve access to other medicines of common interest which may not be available in certain EU markets, such as medicines for rare diseases.
To support the CMA, EMA is already advancing key areas of work. For example, the Act foresees a role for EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) in carrying out supply chain vulnerability assessments to inform measures aimed at addressing structural vulnerabilities in the supply chain of critical medicines. This work will inform decisions on appropriate policy measures to support the strengthening of supply chains of critical medicines, under the new pharmaceutical legislation (e.g. MSSG recommendations) and the CMA (e.g. strategic projects and public procurement procedures).
In preparation for the implementation of the CMA and the new pharmaceutical legislation, the MSSG is evaluating vulnerabilities in the supply chains of a first set of medicines included in the Union list of critical medicines. This list contains over 200 active substances of medicines for human use that are considered critical for healthcare systems across the EU.
The CMA also recognises and strengthens the role of the Quality Innovation Expert Group (QIG) which EMA established in 2022 to support developers of innovative technologies.
EMA is also expanding the functionalities of the European Shortages Monitoring Platform (ESMP), a digital tool designed to enable faster, more consistent and more data-driven exchanges on potential medicines shortages between industry and regulators.
In addition, the Agency welcomes the CMA proposals on state aid and joint procurement, which, while outside EMA’s direct remit, may contribute to improving access to and availability of critical medicines across the EU.
EMA will work closely with the European Commission and EU Member States, in support of the implementation of the CMA.
The CMA was proposed in 2025 by the European Commission in the context of the European Health Union, which seeks to ensure that all EU citizens have access to necessary medicines. It complements regulatory measures already proposed to address medicine shortages and strengthen supply in the EU, notably in the new EU pharmaceutical legislation.