The latest MHRA guidance surrounding clinical trials and Brexit

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released their latest guidance on conducting clinical trials for investigational medicinal products (IMP) after the transition period. It sets out requirements for the registration, publication of summary results and amendments to clinical trials, as well as submitting clinical trial safety reports.

Registration of clinical trials and publication of results

Requirements for registration of a clinical trial remain the same as earlier guidance published in September. Summary results should be published in the public register(s) where the clinical trial has been registered. The summary results do not need to be sent to the MHRA (unless the trial is not on a public register), but a confirmatory email containing a link to the register must be sent to CT.Submission@mhra.gov.uk. In addition to the summary results, a final report needs to be submitted to the Research Ethics Committee (REC) within the same timeframe. The time frame for publishing the summary of results is within 6 months of the end of trial for paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials.

The submission of clinical trial safety reports has also changed. Suspect Unexpected Serious Adverse Drug Reactions (SUSARs) now need to be reported to both the MHRA and the European Medicines Agency (EMA). Development Safety Update Reports (DSURs) and Annual Progress Reports need to be submitted to the MHRA via MHRA Submissions.

Substantial amendments

Changes to the sponsor or legal representative of a UK trial are considered a substantial amendment and require a submission to both the MHRA and the REC.

For trials conducted in the European Union (EU), the sponsor or legal representative must be established in the EU. Updates for ongoing trials in the EU or European Economic Area (EEA) require a substantial amendment to be submitted to the relevant competent authority as per usual. As such, no amendment needs to be submitted to the MHRA for an EU trial when:

  • The sponsor/legal representative is established in the EU/EEA
  • The legal representative for a multi-country study is UK based and an amendment is submitted to other competent authorities
  • The sponsor is UK based but a legal representative that covers the EU/EEA sites is added via submission of an amendment to other competent authorities

If there is a change to any IMP manufacturing, importation or certification site relevant for supply of an IMP to an existing UK trial, a substantial amendment needs to be submitted. If the sponsor retains an existing UK IMP site for the UK trial and includes an EU/EEA release site for trials in the EU/EEA then there is no need to submit a substantial amendment.

When the holder of a Manufacturer’s Authorisation for IMPs (MIA(IMP)) needs to be added to an ongoing trial, the MHRA requires submission of a standard amendment to include the details of the MIA(IMP) holder who is performing the supply chain oversight within one year of 01 January 2021.

Click here to access the full guidance on registration of clinical trials for IMPs.

Click here to access the full guidance on substantial amendments.