European Institutions Confer Expanded Role on European Medicines Agency
- 26/01/2022
- Articles
Following last week’s crucial vote by the European Parliament in favour of a proposed Regulation “on a reinforced role for the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices” (the EMA Regulation), the European Council this week completed the legislative process by signing off on the same text (see, attached European Commission press release of 25 January 2022). The EMA Regulation is scheduled to be published shortly in the EU Official Journal and will apply on 1 March 2022.
The expanded powers provided for by the EMA Regulation will allow EMA to
- monitor and mitigate actual or threatened shortages of medicinal products and medical devices considered as critical to address a European Union wide public health emergency or another major public health event affecting several member states. In the process, the EMA Regulation establishes two distinct shortages steering groups for respectively medicines and medical devices.
- provide advice on medicinal products that have the potential to treat, prevent or diagnose a disease in a public health emergency. Such advice would cover medicinal products under development, those used under national compassionate use programmes, and those already authorised for a different indication but with the potential of being repurposed to treat, prevent, or diagnose the disease at issue. EMA will also have its say over clinical trials designed in this context.
- manage expert panels on medical devices that will assess specific high-risk medical devices relevant for health crisis management and offer scientific crisis preparedness and crisis management advice.
