The Council of the EU has adopted the Regulation enhancing the mandate of the European Medicines Agency (EMA), strengthening the EMA's role in crisis preparedness and management for medicinal products and medical devices. The new mandate will allow the EMA to facilitate coordinated EU-level responses 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, 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.