First version of EU list of critical medicines published

The European Commission, national medicinal authorities and the European Medicines Agency (EMA) have published the first version of the European Union (EU) list of critical medicines. The list includes more than 200 active pharmaceutical ingredients that are widely used in health care in the EU and European Economic Area (EEA). The security of supply of medicinal products containing these pharmaceutical substances should be prioritised and shortages of these products avoided. The EU medicines regulatory network is prioritising action to strengthen the supply chains for these critical medicines.

The list is an important tool for preventing shortages of medicines. Even if an active pharmaceutical ingredient is on the list of critical medicines, there may still be a shortage of medicinal products in the near future. However, the list aims to prevent future supply problems that are particularly harmful to patient care. 

A medicine is considered critical if it is used for a serious condition and no substitute can be easily found. A medicine can be added to the EU list of critical medicines if it meets the requirements of the assessment method, for example if it has been assessed as critical in at least 10 EU/EEA countries.

The list includes active pharmaceutical ingredients from a wide range of therapeutic areas. National lists of critical medicines of six countries has been used as a basis for the list. A list of medicinal products to be stocked as obligatory storage in Finland has also been one of these national lists. The EU list of critical medicines will be extended in 2024 and is updated annually. The list has been assessed using a methodology common to all EU Member States. The method has been developed at EU level in consultation not only with patients and healthcare providers, but also with pharmaceutical industry associations.

The publication of the EU list of critical medicines has no direct impact on existing national lists of critical medicines. However, with the list of critical medicines, the medicines regulatory authorities’ network aims to assist countries that do not yet have national lists. The European Commission has also previously provided information on measures to secure supply chains for critical medicines. 

EMA news 12.12.2023 EU's list of critical medicines
Availability of critical medicines on the EMA website
Methodology to identify the EU's list of critical medicines