A stronger role for EMA

Today, the Council of the EU has adopted the regulation revising EMA’s mandate, officially concluding the legislative process and paving the way for the publication of the new regulation in the Official Journal of the EU over the next few days.

I welcome this successful and rapid conclusion of the inter-institutional negotiations. It will strengthen the Agency’s coordination role in the EU and increase our added value for European citizens, especially in preparing for and responding to future health threats.

The new regulation, which becomes applicable as of 1 March 2022, will put structures and processes established by EMA during the COVID-19 pandemic onto a permanent footing, and entrust new tasks to the Agency.

I am pleased to see that this new regulation acknowledges EMA’s key role in speeding up the development of COVID-19 vaccines and treatments. When the pandemic hit, we adapted our procedures and provided scientific advice to developers, for example on clinical trial protocols, and carried out ‘rolling reviews’ to assess evidence from clinical trials and other studies as they became available. We have seen first-hand how these tools can accelerate clinical trial approval and regulatory assessments in the EU and I’m proud to see that they are now used as part of the blueprint for the EU response to future public health emergencies.

As part of its extended remit, EMA will be?tasked with the monitoring of events, including shortages, in preparation for a crisis situation, as well as with reporting of shortages of critical medicines during a crisis. The Agency will also coordinate responses of EU countries on shortages of critical medical devices occurring in crisis situations, after an initial transition period.

Concretely, EMA will set up and manage a European Shortages Monitoring Platform by early 2025 to facilitate data collection on shortages and supply and demand of critical medicines in the EU. As of 1 March 2022, EMA will also be entrusted with the task to coordinate experts panels providing advice to Member States and the European Commission on high risk medical devices.

I am confident that the extension of our mandate will help us to respond even better to future public health challenges.