New Powers For EMA Under EU ‘Future Proofing’ Plans
EU Is Taking Steps To Strengthen Health Crisis Preparedness
A new legislative proposal is seeking to empower the European Medicines Agency in tracking potential shortages of drugs and medical devices and enable the agency to play a greater role in coordinating clinical trials and vaccine research during health emergencies.
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The new regulation on cross-border threats to health is the final part of the European Health Union, along with strengthened roles for the European Medicines Agency and the European Centre for Disease Prevention and Control. Its aim is to ensure collective EU action on preparedness, surveillance, risk assessment, and early warning and response in the event of health emergencies.
Proposals for establishing a ‘European Health Union’ include measures to give the EU regulator more say in monitoring and mitigating potential and actual shortages of drugs and devices in the event of serious public health crises.
A package of health proposals intended to build up the EU’s resilience to health threats while strengthening the competitiveness of Europe’s pharmaceutical industry and ensuring access to affordable drugs takes a major step through the legislative process this week.