The European Shortages Monitoring Platform (ESMP) has gone live with a core set of functionalities. Using this first version of the ESMP, marketing authorisation holders (MAHs) can now submit data to routinely report shortages of centrally authorised medicines. This marks the start of a transition period that will end on 2 February 2025, when the use of the platform becomes mandatory.
The release of the ESMP is a major milestone in the effort to tackle medicine shortages and ensure that medicines are available to patients when and where they need them most. It will centralise and automate data collection on medicine shortages, giving regulatory authorities access to real-time, comprehensive information to improve the prevention, monitoring, and management of medicine shortages across the EU and the European Economic Area (EEA).
The launch of the functionality for routinely reporting shortages will be followed by the release of the second version of the ESMP in February 2025 with the full scope of functionalities for MAHs and national competent authorities (NCAs). By then MAHs and NCAs will also be able to submit data on the supply, demand and availability of centrally and nationally authorised medicines during crises and preparedness actions led by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). These preparedness actions are taken to monitor and mitigate shortages of a subset of medicines, as was the case, for example with antibiotics in 2023-2024.
The ESMP will also facilitate access to publicly available information on shortages of individual medicines in EMA’s shortages catalogue and national shortages catalogues.
While marketing authorisation holders will still be able to report shortages of centrally authorised medicines via the regular process until 2 February 2025, they are encouraged to familiarise themselves with the platform before its use becomes mandatory after the transition period.
EMA supports users of the ESMP with trainings, webinars (including recordings) and information material available on EMA’s website.
The ESMP is a deliverable of EMA’s extended mandate under Regulation (EU) 2022/123 with the purpose to facilitate information exchange for better prevention, identification and management of shortages, as well as improved communication between EMA, national competent authorities (NCAs) and industry stakeholders to ensure medicine availability for patients during public health emergencies and major events.
Regular updates on timelines and developments as well as information on how to access the ESMP are available on the ESMP webpage.