In 2025, the European Medicines Agency (EMA) recommended 104 medicines for registration. Of these, 38 contained a new active substance that was not previously authorized in the European Union. These drugs represent an important advance in the treatment of various diseases. In December 2025, the EMA added 9 new medicinal products to the Union List of Critical Medicines based on their criticality and the availability of substitutes. The unavailability of these drugs could put patients at risk and disrupt national health systems. Annual updates to the list allow drugs to be added or removed according to current criteria. The list is updated every year to ensure the availability of critically important medicines across the EU.[1]