The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their no-deal Brexit guidance which covers significant amendments to a clinical trial. This includes changes to the trial sponsor/legal representative, investigational medicinal product (IMP) certification and importation and amendments to the Research Ethics Committee (REC).
If there is a change in sponsor or legal representative for a clinical trial in the United Kingdom (UK) then a substantial amendment should be submitted to both the MHRA and the REC. The United Kingdom (UK) requires the sponsor or legal representative of a clinical trial to be in the UK or country on the approved list, which initially would include European Union (EU)/European Economic Area (EEA) countries.
In the event of a no-deal Brexit, the sponsor will need to assign an EU/EEA legal representative 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. It is important to note that no amendment will be required where the sponsor or legal representative for an ongoing trial is established in the EU/EEA. The guidance from the MHRA states additional situations where no amendment is required.
To change, for example to add or replace, any IMP manufacturing, importation or certification site relevant for supply of IMP to an ongoing UK trial a substantial amendment submission to the MHRA is currently required.
As detailed in the MHRA’s further no-deal Brexit guidance note on the regulation of medicines, medical devices and clinical trials, the IMP supply chain from a country on the approved country list, which would initially include EU/EEA countries, will allow direct supply to clinical investigator sites.
The MHRA have stated that after a transition period of one year from the date the UK leaves the EU, “this direct supply must be supervised by a Manufacturing and Import Authorisation for Investigational Medicinal Products (MIA(IMP)) holder who will be required to put in place an assurance system to check these IMPs have been Qualified Person (QP) certified in the EU or EEA.” However, the transition period means that for up to 1 year after the UK leaves the EU, IMPs can be supplied direct from the EEA MIA(IMP) holder to the UK trial site without the UK MIA (IMP).
Furthermore, the Health Research Authority (HRA) have provided guidance regarding when amendments are required to be submitted for REC review.
If there is a no-deal Brexit, this guidance will apply from exit day in line with the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019.
To read the guidance from the MHRA on substantial amendments to a clinical trial if the UK leaves the EU with no deal, please click here.