New EU Bodies To Monitor Drug Supply In Health Crises
New pandemic-related responsibilities have been entrusted to the European Medicines Agency by a regulation published on 31 January. They include coordinating vaccine safety and effectiveness studies and setting up a European network of real-world data to help support health crisis preparedness and response.
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During the recent Medicines for Europe 2022 annual conference, held in Sitges, Barcelona, the EMA’s head of supply and availability of medicines and devices, Monica Dias, provided delegates with a detailed update on plans to implement the agency’s major shortages monitoring platform by early 2025.
A new EU regulation has come into effect, giving the European Medicines Agency wider powers to monitor, prevent and manage shortages of medicines and medical devices in public health emergencies. A number of steering groups and other bodies and networks are being set up to put the new systems into action.
The more products the European Medicines Agency approves, the more post-authorization applications it receives, leading to an ever-growing spiral in its workload. This, together with the increase in COVID-19-related tasks, new responsibilities in clinical trials and other areas, and a decline in staff numbers over the years, is posing some real resource issues at the agency.