Europe starts planning for drug monitoring and approval post-Brexit

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The European Medicines Agency expects all EU/EEA Member States to pull their weight.

The European Medicines Agency (EMA) has initiated discussions with EU/EEA Member States on the process of evaluating and monitoring medicines post-Brexit.

Although negotiations on the UK’s departure from the EU have not yet officially commenced, work will now start on the basis that the UK will no longer participate in the work of the EMA and the European medicines regulatory system as of 30 March 2019, the agency said in a statement .

“I am reassured to see the overall commitment of the Member States to step up their efforts and to explore the options to take on a bigger share of the workload,” said EMA Executive Director, Guido Rasi at a meeting of the EMA’s management board and European national regulatory authorities last week. “The expertise available across the network is impressive and this is an opportunity to streamline the way we work, increase our capacity and work even more efficiently.”

The transition will include a process of mapping current and future capacity and expertise in the region, and identifying potential gaps. The EMA, and National Competent Authorities will now assess the different options for workload distribution, and are due to meet again on 5 July 2017.


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