As part of the on-going work to build a strong European Health Union, the Council has adopted the Regulation revising the mandate of the European Medicines Agency (EMA), taking an important step towards EMA’s reinforcement in crisis preparedness and management for medicinal products and medical devices.
The new rules will allow the Agency to closely monitor and mitigate shortages of medicines and medical devices during major events and public health emergencies and facilitate faster approval of medicines which could treat or prevent a disease causing a public health crisis.
The adoption of a stronger mandate for EMA is part of the European Health Union package proposed by the Commission in November 2020.
Thanks to its reinforced mandate, the Agency can facilitate a coordinated EU-level response to health crises by:
- monitoring and mitigating the risk of shortages of critical medicines and medical devices;
- providing scientific advice on medicines that may have the potential to treat, prevent or diagnose the diseases causing those crises;
- coordinating studies to monitor the effectiveness and safety of medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;
- coordinating clinical trials for medicinal products intended to treat, prevent or diagnose diseases related to the public health crisis;
- transferring the expert panels of the Medical Device Regulation to the Agency.
The legislation also formally establishes the Medicines and Medical Devices Shortages Steering Group and the Emergency Task Force, working on the above tasks.
Following the formal signing of the Regulation by the European Parliament and the Council today, it will be published in the Official Journal. The Regulation will enter into force on the day following its publication and will apply from 1 March 2022. The Regulation’s provisions on shortages monitoring of medical devices, except for the transfer of the expert panels, will apply 12 months after the entry into force of the Regulation.