The European Union network of medicines authorities [Heads of Medicines Agencies (HMA)][1], the EMA (European Medicines Agency) and the European Commission published on the 12th of December 2023 the first version of the List of Critical Medicines of the European Union.
This list contains more than 200 active substances in medicinal products for human use that are considered critical for health systems in the EU/EEA, for which continuity of supply is a priority and their disruption or shortage should be avoided. It contains active substances (including innovative medicines and generic medicines) covering a wide variety of therapeutic areas.
The EU medicines regulatory network will prioritise these medicines for decision-making at EU level in order to strengthen their supply chain and minimise the risk of supply disruptions.
The Union list will be extended in 2024 and will subsequently be updated annually. This list will not interfere with the lists of essential medicines at national level.
The Union list supports the European Commission’s ongoing review of supply chains to determine current vulnerabilities, as outlined in the Commission’s Communication of 24 October.