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<p>Currently, rare diseases are defined as conditions affecting no more than five
in 10,000 people in the European Union. The new European Clinical Trial Regulation
(Regulation (EU) No 536/2014) will introduce an ‘ultra-rare’ condition and states
that clinical trials for the development of orphan medicinal products and those of
medicines affecting no more than one person in 50,000 in the EU (ultra-rare diseases)
should be fostered, and in such areas, a rapid yet in-depth assessment is of particular
importance. The new clinical trials regulation is expected to be implemented in the
EU in late 2020. The Government has confirmed that United Kingdom law will remain
aligned with the parts of the new EU clinical trials Regulation that are within the
UK’s control.</p>
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