UK Sets Three New Post-Brexit Policies for Clinical Trials
In its ongoing effort to replace EU clinical trial policies with UK-specific guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued three clinical trial guidances on registering and publishing results of trials, submitting safety reports and making substantial changes to trial applications.
Trials conducted in the UK should register with and report results to one of the international trial databases, according to the first guidance, such as ClinicalTrials.gov in the U.S. or the International Standard Randomized Controlled Trial Number (ISRCTN) registry recognized by the World Health Organization. Trials with sites in both the UK and the EU can use the EU Clinical Trials Register.
The second guidance directs trials to submit Suspected Unexpected Serious Adverse Reaction (SUSAR) reports through the MHRA gateway, the eSUSAR website or MHRA’s Individual Safety Case Reports submission portal. For trials operating in both the UK and the EU, SUSAR reports must be submitted to MHRA, the relevant EU member state and the European Medicines Agency’s Eudravigilance Clinical Trial Module.
Sponsors that need to make substantial amendments to their trial applications, such as a change of sponsor or legal representative or addition of a license holder to the existing marketing authorization, must inform both MHRA and the UK’s Regulatory Ethics Committee, according to the third guidance.