The UK Government has published new guidance on how medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal
Importantly, in relation to the reporting of clinical trials, the guidance states that:
‘The 2004 Regulations will remain in force, modified using powers under the EU (Withdrawal) Act (EUWA) to make sure they still work in the UK after exit.
The new EU Clinical Trials Regulation (CTR) 536/2014 will not be in force in the EU at the time that the UK exits the EU and so will not be incorporated into UK law on Exit day under the terms of EUWA.
However, we’ll align where possible with the CTR without delay when it does come into force in the EU, subject to usual parliamentary approvals. This alignment will happen after 29 March 2019 so it’s not addressed in this guidance.’
As such, although a little vague, it would appear that the UK will align with the CTR, meaning that lay summaries will be required for trials where there is at least one trial site in the UK.
As with anything Brexit-related, this should probably be taken with a pinch of salt, as things could change overnight. However, at least for now there seems to be some degree of clarity going forward.