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EC, HMA, and EMA Release the Initial Version of the Critical Medicines List to Ensure Supply Security

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The European Commission (EC), in collaboration with the Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA), has unveiled the first iteration of the Union list of critical medicines. This comprehensive list comprises over 200 active substances used in human medicines and is deemed essential for healthcare systems across the EU/EEA. These medicines are prioritized to ensure a continuous supply, and steps will be taken at the EU level to fortify their supply chains.

The list serves as a crucial tool to bolster the EU’s efforts in securing the availability of critical medicines and preventing potential shortages. Inclusion on this list doesn’t imply an imminent shortage but underscores the significance of safeguarding their supply due to the potential harm to patients and healthcare systems if shortages occur. Medicines are classified as critical if they are indispensable for treating serious diseases and lack easy substitutes. A medicine makes it onto the Union’s list of critical medicines if it meets specific criteria, including its criticality in over one-third of EU/EEA countries.

Comprehensive Evaluation and Expansion Plans for the Union List of Critical Medicines

The list encompasses active substances spanning various therapeutic areas, encompassing vaccines and medicines for rare diseases. It is the result of an evaluation of 600 active substances drawn from six national lists of critical medicines. The Union list will see expansion in 2024, with annual updates thereafter. This review was conducted in collaboration with all EU Member States, and the criticality classification was based on a jointly developed methodology in consultation with key stakeholders, including patient and healthcare professional organizations, as well as industry associations.

Patients and healthcare professionals can continue to prescribe and use medicines on the list as usual. Additional reporting requirements for marketing authorization holders and national competent authorities will be established and enforced once the proposed pharmaceutical legislation comes into effect.

Critical Medicines

Union List’s Impact on National Lists and Measures to Prevent Medicine Shortages

The release of the Union list will not affect existing or forthcoming national lists of critical medicines. However, it will aid the network in creating national lists where they are currently lacking. Additionally, it will support the EC’s analysis of the supply chain for critical medicines to identify potential vulnerabilities, as outlined in the EC’s communication from October 24. The EC and EMA’s Medicines Shortages Steering Group (MSSG) may propose measures to address supply vulnerabilities, ultimately preventing and mitigating shortages.

The Union list of critical medicines complements other measures undertaken by the EMA/HMA task force on the availability of authorized medicines and the MSSG. These measures include good practices for the industry and stakeholders to prevent medicine shortages, the newly introduced MSSG solidarity mechanism, the MSSG toolkit, and recommendations for averting shortages of key antibiotics used in treating respiratory infections.


Resource: European Medicines Agency, December 12, 2023

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