UK unveils no-deal Brexit contingency legislation for clinical trials

25th January 2019 (Last Updated January 25th, 2019 08:49)

The UK Government has revealed a contingency legislation for the Medicines and Healthcare products Regulatory Agency (MHRA) to regulate clinical trials in case of a no-deal Brexit.

The regulation, which is subject to Parliament approval, will require the MHRA to authorise all drug trials. Furthermore, the legislation requires the studies to be conducted in line with Good Clinical Practice.

In addition, the government outlined requirements for the evaluation and supply of investigational medicinal products as well as safety reporting.

The legislation also includes multiple amendments to the Clinical Trials Regulations, including instructions for interpretation, sponsor of a trial and authorisation procedure.

The government also published two separate contingency legislations for medicines and medical devices, respectively, in case the UK had to leave the European Union (EU) without an official deal.

This announcement comes soon after a report that universities in the UK have failed to post data from nearly 1,671 clinical trials onto registries, violating reporting rules.

In this regard, UK Science and Technology Select Committee chair Norman Lamb has written to more than 40 universities on their practices to meet clinical trials transparency requirements.

The universities have been asked to ensure that measures are taken to comply with existing transparency rules and legislation in the future.

Lamb said: “The Committee applauds the universities that have reacted quickly to the clinical trials transparency problems we identified in October.

“However, it’s deeply disappointing that on the face of it most have failed to respond to the challenge so far. Universities and other trial leaders need to act on this as a matter of urgency.”

The Committee intends to carry out a follow-up evidence session regarding the trial transparency issue.