knowledge 22 January 2026 |

EU Critical Medicines Act: What life sciences companies need to know

The EU CMA and the EU pharma reform package

Originally proposed by the European Commission in March 2025, the EU CMA is designed to complement the landmark reforms to the EU’s existing legislative framework for pharmaceuticals (the EU pharma reform package).  The EU CMA and the EU pharma reform package are both component parts of the European Health Union, and both address different aspects (regulatory and industrial) of the efforts to combat medicine shortages.   Those shortages can be triggered by a wide range of issues, including disruptions in the manufacturing process, over-concentration of production in a small number of countries, unexpected increases in demand, and global competition for resources.

The EU pharma reform package (due for publication in the Official Journal shortly) focuses on adjustments to the regulatory framework with a view to ensuring fast, fair and safe access to medicines, reducing regulatory burdens, streamlining how the European Medicines Agency (EMA) functions, and improving security of supply.  For more information on the planned EU pharma reforms, read our December 2025 analysis here: EU Agrees Landmark Reform of Pharmaceutical Legislation. 

What is the EU CMA’s focus?

While the EU pharma reform package focuses on the regulatory side, the EU CMA focuses on the industry side and includes proposals designed to enhance manufacturing capacity and diversify supply chains.  The EU CMA aims to ensure:

• security of supply and availability for critical medicines (generally medicines where there is a lack of alternatives, where supply shortages could result in serious harm, or where there are vulnerabilities in supply chains – the current Union List of Critical Medicines lists over 270 critical medicines, and will be formalised as part of the EU pharma reform package), and
• accessibility and availability of certain other medicines of common interest which might not be widely accessible (e.g. for certain rare diseases). 

To do this, the EU CMA is built on four key pillars: investment and support for strategic projects, incentives for supply chain diversification and resilience, EU support for collaborative procurement, and strategic partnerships with third countries / regions to diversify supply chains and reduce dependencies on single suppliers.  The proposal involves:

• The ability for the Commission to designate strategic projects (projects that create, increase or modernise EU manufacturing capacity of critical medicines, their active substances and other key inputs) – those projects will be able to benefit from faster permits, regulatory and scientific support, and financial support.
• In terms of public procurement, mandatory use of non-price requirements (such as diversified sources of input material and monitoring of supply chains) for critical medicines; requirements to favour EU production for specific critical medicines with high dependencies; the potential to favour EU production of other medicines of common interest where justified; requirements for EU Member States to put national procurement practice programmes in place; and Commission guidelines on procurement practices.
• Collaborative procurement provisions (cross-border procurement (as between EU Member States) for medicines of common interest), Commission procurement on behalf of Member States (critical medicines) or joint procurement (Commission and Member States) (critical medicines).
• International cooperation (strategic partnerships aimed at diversifying supply chains, and establishment of a Critical Medicines Coordination Group).

Next steps

With trilogue negotiations looming, the final shape of the EU CMA may look slightly different to its current form.  The EU Council was quite procurement-focused when formulating its position on the EU CMA in December 2025 (see here: Critical medicines act: Council agrees its position on new rules to tackle shortages). Both the EU Council and the European Parliament are expected to push for a reduction (from nine) in the number of Member States that need to submit a joint request to the Commission for collaborative procurement.  Better collaboration between member states on contingency stocks of medicinal products will also be a focus.

Keeping you up-to-date

Keep an eye out for detailed analysis from our market-leading Life Sciences Group as the final shape of the EU CMA becomes clear once trilogue negotiations complete.