Brexit spells upheaval for EU and UK drug regulation

Reuters

24 June 2016 - Britain's vote to leave the European Union spells regulatory uncertainty for drug companies, with the London-based EMA, which approves treatments for all EU countries, expected to have to relocate.

The association of Germany's pharmaceuticals industry said on Friday that Europe's equivalent of the U.S. FDA would need to move to a city within the EU, bringing administrative headaches for companies.

Britain's biggest drugmaker, GlaxoSmithKline, said the exit vote "creates uncertainty and potentially complexity for us in the future", though the impact on its global business would be small, while the UK pharma trade association warned of challenges to future investment, research and jobs.

Industry executives fear upheaval at the EMA could snarl the EU's drug approval process and Britain may have to develop its own domestic regulatory system, leading to further confusion.

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Michael Wonder

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Michael Wonder

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Medicine , Europe , Regulation