5 March 2019

KCR Memo: What’s next for Brexit?

The Big Ben is running quickly towards Brexit, with the UK being scheduled to leave the European Union at 11 pm UK time on Friday, 29 March 2019. The pharmaceutical and research industries will face significant changes if the UK departs the EU, especially in a no-deal Brexit, as the status shows. Curious about the implications?

A no-deal would result in an immediate exit from the EU without the possibility of a transition period, leaving organizations with no time to adjust or respond to the sudden changes.

For instance, the UK’s national regulator for human medicines - The Medicines and Healthcare products Regulatory Agency (MHRA), will cease to be part of the European regulatory network and will take the responsibilities currently performed by the EMA for centrally authorized products medicines on the UK market, including manufacturer batch testing and certification. This transfer of power would require the development of new laws in the UK.

Additionally, research companies that run clinical trials in European Union countries (UK included) will need to consider additional conditions from their regular ones, such us using UK manufactured substances, insurance and legal presence. There will be also an impact for US-UK trade relations, which should be regulated by a bilateral free trade agreement. This would be negotiated once the UK leaves the EU.

If you’re interested in learning more, KCR sheds light on what you can expect from the clinical research industry after Brexit in the UK, US, and EU in a concise summary.

A no-deal would result in an immediate exit from the EU without the possibility of a transition period, leaving organizations with no time to adjust or respond to the sudden changes.

If you would like to learn more on Brexit implication or about our Trial Execution Consulting services, please contact us at pr@kcrcro.com. Please include your contact details in the query.

 

KCR is a contract research organization providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries. The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Trial Execution Consulting (TC) over a broad range of therapeutic areas.

KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, U.S., Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies.

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Joanna Lewandowska
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pr@kcrcro.com