Bio/Pharma and Brexit

The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.

The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.

The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.

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.

Following the United Kingdom’s decision to leave the European Union, there are two areas that demand attention-clinical trials and marketing authorization

The agency says, for now, it’s business as usual.The European Medicines Agency (EMA) says the future location of the agency will be determined by common agreement between representatives of the Member States, according to a July 6, 2016 statement. Until then, EMA says it will be conducting business as usual, and the outcome of the June 23 referendum will not affect the agency’s operations.

In the wake of Britain’s decision to exit the EU, pharma companies face uncertainty.

Members of ABPI, GSK, AstraZeneca, and the BioIndustry Association composed a letter explaining why the UK remaining part of the EU benefits the life-sciences sector.