EMA published its first annual update of this list in December 2025. It updates the list annually.
Union list of critical medicines
Medicines on the Union list are prioritised for EU-wide actions to strengthen their supply chains and minimise the risk of supply disruptions.
EMA also uses this list in the establishment of a product management database to support the standardisation of product information in the EU and in the European Economic Area (EEA).
The list includes innovative medicines and generic medicines for human use. These medicines cover a wide range of therapeutic areas - such as vaccines and medicines for rare diseases.
Gilead's active products in the list are: AZITHROMYCIN (Cayston); AMPHOTERICIN B (Ambisome); EMTRICITABINE (Emtriva); SACITUZUMAB GOVITECAN (Trodelvy).
EMA, HMA and the Commission drafted the list in phases. At the end of 2024, the list reflected 2,200 substances groups and combinations. These accounted for 75% of the authorised medicinal products in the EU.
The European medicines regulatory network drew these active substances from existing lists within the network. These include the list of main therapeutic groups and national lists of critical medicines.
The network added 9 substances groups to the list in 2025, after it reviewed an additional 61 active substances.
The network published the first version of the list in December 2023, followed by the second version of the list in December 2024. It published the first annual update of the list in December 2025. Annual updates ensure that the network can add to the list medicines that meet so-called criteria for criticality. Annual updates also enable the network to remove medicines that no longer meet these criteria.
EU Member States assign critical medicine status based on a methodology developed with input from key stakeholder groups. This includes patient and healthcare professionals organisations, and pharmaceutical industry associations.
A critical medicine is identified by combining two criteria:
- Seriousness of the disease
- Availability of alternative medicines
A medicine also has to meet additional criteria to be included in the list, such a defined number of Member States that consider the medicine to be critical or the marketing status of the medicine.
A questions and answers document on the Union list is available.
Methodology to identify critical medicines for the “Union List of critical medicines
The European medicines regulatory network will closely monitor the medicines on the Union list and implements measures to minimise the risk of supply disruptions. It will do so via existing processes and structures, as defined in the mandate of EMA’s Medicines Shortages Single Point of Contact (SPOC) Working Party and its Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG).
Additional obligations for marketing authorisation holders and national competent authorities are further defined in the upcoming proposed EU pharmaceutical legislation.
The European Commission has analysed the vulnerabilities in the supply chain of selected critical medicines in the Union list. In July 2024, the Commission published the main findings for the first tranche of 11 critical medicines in a technical report.
In October 2023, the Commission published a communication on addressing critical shortages of medicines. This document lays out the plans for regulatory and industrial policy measures to address supply chain vulnerabilities.
The Commission may propose measures to address vulnerabilities and strengthen security of supply for critical medicines, including:
- recommendations for companies to diversify suppliers or increase production within the EU;
- incentives for investment;
- additional regulatory obligations for companies;
- procurement with strong contractual obligations for delivery.
These measures will support the prevention and mitigation of shortages, and ensure appropriate and continued supply of critical medicines for patients and healthcare systems across the EU.
For more information, see: