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<p>The Government values the strong collaborative partnerships that we have across
the European Union in the areas of science, research and innovation, and as part of
exit negotiations is working to ensure that we have the best possible environment
in which to support the United Kingdom medical research sector and patient access
to cross-border clinical trials after we leave the EU.</p><p>In the United Kingdom,
the Medicines and Healthcare products Regulatory Agency, Health Research Authority,
ethics services, National Institute for Health Research and the National Health Service
have been working towards implementation of the new European Clinical Trials Regulation
(CTR) since it was agreed in 2014. The application date of the CTR across the EU is
yet to be set by the European Commission, but is expected to be in 2019.</p><p>Whatever
the outcome of the UK’s EU exit negotiations, the current regulatory approval legislation
will stay in place until such time as any changes are needed, so there will be no
interruption in UK clinical trials approval. The EU Withdrawal Bill will make the
current UK clinical trials regulations (2004 2001/1031) that implement the clinical
trials directive (2001/20/EC) operable on exit day and this is not contingent on any
decision about whether the CTR will apply in the future.</p>
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