Council agreement paves way to reinforce European Medicines Agency

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The Council has reached an agreement on draft rules to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices.

Member states agreed changes to the original proposal which aim to clarify the financial and data protection provisions. They stress that transfers of personal data in the context of the new EMA mandate will be subject to EU data protection rules such as the General Data Protection Regulation. Other changes relate to the composition and functioning of the Emergency Task Force, in particular its advisory role when it comes to developing clinical trials for medicinal products intended to deal with a health emergency.


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