For years, medicine shortages in Europe were tracked the way a household tracks its pantry: informally, unevenly, and usually only after the shelf was already bare. That is changing, and the European Medicines Agency’s newly published 2025 annual report, released on 11 June, offers the clearest picture yet of how fast the infrastructure for spotting and managing shortages has matured, just as lawmakers hand the agency a much bigger job.
The centrepiece of that infrastructure is the European Shortages Monitoring Platform, which the agency confirms became fully operational during 2025. The platform allows marketing authorisation holders and national regulators to report, in something close to real time, on the supply, demand and availability of medicines that are either centrally authorised or sold nationally. It is overseen by the agency’s steering group on shortages and safety, the body that coordinates the EU’s response when a medicine that patients depend on suddenly becomes hard to find.
That monitoring capacity arrives just as it is about to be tested at much greater scale. On 12 May, the European Parliament and the Council reached a provisional agreement on the Critical Medicines Act, legislation that designates the EMA as the central operational authority for assessing supply chain vulnerabilities across more than 200 active substances on the EU’s critical medicines list. In practice, that means the agency moves from monitoring shortages as they happen to running structured vulnerability assessments before they happen, mapping where the raw ingredients, manufacturing capacity and finished-product supply for the most essential medicines actually sit, and how exposed each link in that chain is to disruption.
The shift matters because the vulnerabilities are not hypothetical. Much of the active pharmaceutical ingredient production for widely used antibiotics, painkillers and generic drugs has migrated to a small number of manufacturing sites outside Europe over the past two decades, concentrating risk in ways that became starkly visible during recent shortages of basic antibiotics. A platform that tells regulators a shortage is happening is useful; a process that tells them, in advance, which of 200-plus essential substances are one factory closure away from a European-wide shortfall is a different order of capability, assuming the underlying data holds up.
The agency’s own report also flags the breadth of its day-to-day workload, noting 104 new medicines approved for human use in 2025, including a number of first-in-class therapies, alongside its ongoing safety work. Its pharmacovigilance committee’s most recent meetings, running from 8 to 11 June, concluded a review of neurodevelopmental risks linked to valproate use in male patients and tightened liver-monitoring requirements for at least one other drug, a reminder that shortage prevention is only one strand of an agency whose core job remains judging whether medicines are safe enough to stay on the market at all.
The Critical Medicines Act still needs to clear final adoption before its provisions take full effect, and turning a list of 200 substances into genuinely actionable vulnerability assessments will require data-sharing from manufacturers who have not always been eager to disclose supply chain details. But the direction is clear: after years of being told to watch for shortages, Europe’s medicines regulator is now also being told to get ahead of them.
