A regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123 “on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices”).
The regulation will apply from 1 March 2022 (with the exception of the provisions on shortages of critical medical devices, which will apply from 2 February 2023). The document also assigns several new tasks to the EMA. For example, as part of its extended mandate, EMA will be entrusted with monitoring potential crisis situations. These include, for example drug shortages and shortages of critical medicines. To this end, the EMA is to establish, maintain and manage a European medicines shortage surveillance platform by early 2025.
The EMA has also been given responsibility for coordinating several EU expert panels to advise Member States and the European Commission on high-risk medical devices and in vitro diagnostic medical devices.
The aim of the Regulation is thus to ensure the smooth functioning of the internal market for medicinal products and medical devices in crisis situations. In addition, this regulation aims to improve the quality, safety and efficacy of medicinal products for emergencies.