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Compliance In Focus
Posted by Melissa Wollerman on Tue, Oct 23, 2018

What Does Brexit Mean for Clinical Research?

As Brexit negotiations continue between the UK and EU, clinical research sponsors are Brexitcarefully considering the future of research in the UK, as the number of clinical trials held there has begun to decrease. From an average of 806 trials a year conducted between 2009 and 2016, to 597 trials in 2017, the numbers have diminished by over 25 percent. One medical research firm based in the US has halted its clinical trial activities in the UK due to the uncertainty in approval of medicines and acceptance of data by the European Medicines Agency.

Along with the larger debate of how the UK will part from the EU, there is an even larger question for the clinical research industry. How is the extent of Brexit going to impact clinical research conducted in the UK, and how will this affect the global medicines and devices markets? The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) clarified how clinical trial requirements will function during the implementation period that will begin on March 30th, 2019 and last until December 31st, 2020. The agency released a statement that EU rules and regulations will remain in place during the transition. Although the UK will no longer be a member of the EU, this will provide continuity to businesses and citizens.

Expected to be implemented in early 2020, the EU’s Clinical Trials Regulation (CTR) will enable a streamlined application process, a single portal for all EU clinical trials, consistent assessment procedures, and simplified reporting procedures. If the EU CTR goes into effect prior to the end of the Brexit implementation period, the regulation will therefore be observed in the UK. If the CTR implementation is delayed, the MHRA has indicated it will work to adopt the CTR, but the details are uncertain.

In the event the regulation is not applied by the time the Brexit implementation period has been exhausted, the UK will have greater difficulty in adopting processes and regulations. The Government, however, has taken steps to decrease the likeliness of this happening by confirming UK law will remain aligned with parts of the EU’s Clinical Trails Regulation, allowing researchers to plan with greater certainty.

Has the looming Brexit implementation period affected your clinical research studies or plans? Will you potentially be affected if the EU Clinical Trials Regulation is not in effect in the UK by the end of the Brexit implementation period? What steps are you taking to ensure you are prepared for such a change?

eTMF Auditing CTA - Blog

photo credit: Leo Reynolds union jack via photopin (license)

Topics: Brexit


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