Clinical trials in the post-Brexit world

Once the UK leaves the EU, it will cease to participate in the European regulatory network for clinical trials, and regulatory responsibilities would shift to the MHRA. The UK government guidance Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021 (1 September 2020) and Guidance on substantial amendments to a clinical trial from 1 January 2021 (1 September 2020) set out the latest position in relation to clinical trials after the transition period ends.

This latest guidance does not address the status of existing approvals for clinical trials (both regulatory and ethics), or whether the UK will seek to align with the EU Clinical Trials Regulation. It is anticipated that further guidance on the requirements of registration and reporting of trials will be to come.

The latest guidance addresses requirements for the sponsor and legal representative for a clinical trial. After the transition period ends, the UK will require the sponsor or legal representative of a clinical trial to be in the UK or country on an approved country list (this will initially include the EU/EEA countries). For ongoing trials, the UK will accept a sponsor or legal representative established in the EU/EEA, and no amendment submission to the MHRA will be required.  Where the sponsor is from the rest of the world, and the legal representative is established in the UK and there are sites elsewhere in the EU/EEA, the sponsor will need to assign an EU/EEA legal representative for these EU/EEA sites.

Transparency provisions are also clarified in the latest guidance. From 1 January 2021, those running trials should continue to use existing and established international registers such as ISRCTN registry (UK) or ClinicalTrials.gov (USA). Trials that involve both UK and EU sites, there will be a record in the EU Clinical Trials Register (other than for adult Phase 1 studies). In the UK, a favourable opinion given by a research ethics committee is subject to the clinical trial being registered. The UK will continue to make information UK trials publicly available via the Health Research Authority website and the UK “Be Part of Research” website. A summary of results for UK trials must be published on the public registers where the clinical trial is registered within 6 months of the end of trial (paediatric clinical trials) or within one year of the end of trial (non-paediatric clinical trials). Confirmation that the summary of results has been published should be emailed to the MHRA. The same timeframes apply to the submission of a final report to the Research Ethics Committee of the Health Research Authority.

Importers of Investigational Medicinal Products (IMP) to a UK clinical trial site will require a Manufacturers Licence (MIA). Sponsors will have up to 1 year after the end of the transition period to submit a substantial amendment to the MHRA to include the details of the MIA holder performing the “supply chain oversight” role. No substantial amendment is required if the sponsor retains an existing IMP release site in the UK for an ongoing UK trial but includes an additional EU/EEA site for trials in the EU/EEA only.

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