The MHRA has released a statement on the regulation of clinical trials once the UK leaves the EU, saying its ‘overall aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines.’
The agency said EU regulations would remain in place during the ‘implementation period’ of Brexit from 30 March 2019 to 31 December 2020 – when the UK is no longer part of the EU but will keep EU rules and regulations to provide certainty.
A new EU clinical trials regulation is expected to come into force during this implementation period, and would therefore apply to the UK.
If the new regulation does not come into force during the implementation period, the UK government’s position is that ‘UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, in order that researchers conducting clinical trials can plan with greater certainty.’
There are two parts of the new EU regulation the UK would not be able to implement on its own after the end of the implementation period: the use of a shared central IT portal and participation in the single assessment model.
These two parts would require a UK/EU agreement about UK involvement after the end of the implementation period.
