EMA Plots Workload Shift Ahead of UK Experts' Departures in 2019

Regulatory NewsRegulatory News | 28 April 2017 |  By 

With a meeting yesterday between the European Medicines Agency's (EMA) Management Board and heads of the National Competent Authorities of the EU/EEA member states, a discussion was initiated on how to share the work of evaluating and monitoring medicines without the UK's help.

"Although negotiations on the terms of the UK's departure have not yet officially commenced and one cannot prejudge their outcome, work will now start on the basis of the scenario that foresees that the UK will no longer participate in the work of EMA and the European medicines regulatory system as of 30 March 2019," EMA said on Friday.

The agency noted that some general principles for workload distribution will include: ensuring continuity; maintaining the quality and robustness of scientific assessments; continuing to comply with legal timelines; ensuring knowledge retention, either by building on existing knowledge, or through knowledge transfer.

"The envisaged working methodology will include a mapping of current and future capacity and expertise in the network and the identification of potential gaps. This could help the network to increase its capacity in selected areas, and would be supported with enhanced training opportunities," the agency added.

Member state representatives will determine where the agency's headquarters move and EMA said it welcomes the interest expressed by some member states in hosting the agency in future. 

"EMA is confident that the member states will make the most appropriate decision on the agency's location and arrangements, taking the complex political and legal environment generated by the outcome of the UK referendum into account," the agency said.




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