EMA and EU Member States Begin Brexit Discussions

On April 28, 2017, the European Medicines Agency announced that it met with members of the heads of the National Competent Authorities (NCAs) of the member states of the European Union to discuss the United Kingdom’s exit from the EU (Brexit) and how the agency and the member states will handle the evaluation and monitoring of drugs going forward. EMA stated in a press release that, although Brexit actions have not officially begun, the agency will proceed under the assumption that the UK will no longer participate in the European regulatory system as of March 30, 2019.

At the meeting, it was decided that the expertise and capacity of the NCAs will be assessed, and depending on their capacity and capabilities, the NCAs will contribute to EMA activities. The planned workload distribution will be designed to ensure business continuity, maintain the quality of risk assessment, continue to comply with legal timelines, ensure knowledge retention and transfer, and assure easy implementation and sustainability. EMA has a follow-up meeting scheduled for July 5, 2017.

“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’s Executive Director Guido Rasi at the meeting. “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.”