Brexit, EMA

Can the UK stay in the EMA post-Brexit?

On July 17, 2018, the UK Parliament voted to remain in the European Medicines Agency (EMA) after Britain withdraws from the European Union (“Brexit”).

This is not a done deal: the vote only means that the UK government must negotiate to continue to participate in the EMA. This will probably involve negotiating an appropriate payment to participate.  There is some precedent for this, such as Swiss participation in the European Aviation Safety Administration (EASA), and Europol. The UK would also have to agree to follow the regulations the EMA has put in place.

RAPS Regulatory Focus quotes a statement from Mike Thompson of the British Pharmaceutical Industry, and Steve Bates of the BioIndustry Association:

Parliament has sent a clear message that patients and public health should be a top priority for the Government in these negotiations. Every month, 37 million packs of medicine arrive in the UK from the EU and 45 million move the other way. Therefore, it is essential that the UK continues to participate in the EMA after Brexit, as set out in the Brexit White Paper and in the Prime Minister’s Mansion House speech.

The ramifications of this are far reaching: Without such an agreement, the UK would need to implement its own regulations of medicines, or just recognize other authorities’ approvals without the opportunity to adjust those decisions for the safety of the UK population.  This could mean that down the line fewer drug companies would seek approval in Britain, meaning that fewer new medicines would be available.

The Parliamentary statement can be found in a document titled “The Future Relationship between the United Kingdom and the European Union” — but it’s full of pretty dry legalese. Please contact ACUTA for more information on the impact of Brexit, and how we can help you prepare for separate submissions and managing submissions and registrations using the ARIM Regulatory Information Management system.

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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