EMA Working Out Workload Woes From Brexit

The EMA is considering how to redistribute the work of drug approval and oversight among European Union member states after Brexit.

Though negotiations on the terms of the U.K.‘s departure have not officially started, the EMA is operating with the understanding that the U.K. will no longer participate in the European medicine regulatory system as of March 30, 2019, according to the agency.

EMA’s concerns include how best to ensure business continuity and knowledge sharing, keep up with compliance deadlines, and maintain the quality of scientific assessment.

EMA’s management board and the heads of member states’ National Competence Authorities met in late April to discuss contingency plans. EMA’s Executive Director Guido Rasi, said he was reassured to see the commitment of the member states to step up their efforts and to explore options to take on a bigger share of the workload.