Strengthening the responsibilities of the European Medicines Agency (EMA) enables the European Union to ensure that basic medicines and medical devices are available to the public at all times, said Health Commissioner Stella Kyriakidou on the occasion of the adoption of the relevant regulation by the EU Council on Tuesday.
"With a strengthened Organization, we can ensure that basic medicines and medical devices are available to our citizens at all times and that new medicines that come to deal with emergencies can be approved faster," said Ms. Kyriakidou.
"Building a strong European Health Union is a vision we all share and I would like to thank both the European Parliament and the Member States for their commitment and dedication to implementing this important project," Kyriakidou added.
Following the strengthening of its mandate, which will take effect on 1 March, Coreper will contribute to coordination in dealing with health crises at EU level through:
- monitoring and mitigating the risk of shortages of critical medicines and medical devices,
- the provision of scientific advice on medicines and medical products which may contribute to the treatment, prevention or diagnosis of diseases which give rise to a particular health crisis,
- the coordination of studies to monitor the efficacy and safety of medicines and medical products related to the specific health crisis,
- the coordination of clinical trials for medicines and medical products related to the specific health crisis, and
- the transfer of expert groups whose work concerns the provisions of the Medical Devices Regulation to the competence of the European Medicines Agency.
The legislation also formally creates the working groups that will undertake the above actions.
The provisions of the new regulation concerning the monitoring of shortages of medical devices (excluding the transfer of expert teams) will enter into force 12 months after the entry into force of the regulation.