MHRA release guidance on submitting clinical trial safety reports from 1 January 2021

How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs) at the end of the Brexit transition period.

From 1 January 2021, SUSARs detected in clinical trials in Great Britain (GB) and Northern Ireland (NI) will need to be reported to the MHRA via:

  • eSUSAR website
  • ICSR Submissions
  • MHRA Gateway

Sponsors and Contract Research Organisations (CROs) will need to be registered to either the ICSR Submissions or the MHRA Gateway to enable configuration of their systems before 1 January 2021 in order to submit SUSARs to the MHRA. In order to differentiate SUSAR reports from post-marketing ICSRs, the new MHRA reporting systems will enable sponsors to specify the type of report as a study and assign the study type as a clinical trial.

SUSARs currently reported using either EVWEB or the Eudravigilance Gateway are transmitted to the MHRA via the EMA’s Eudravigilance system. From 1 January 2021, for trials conducted in both the UK and EU dual reporting will be required to both the MHRA and the European Medicines Agency’s (EMA’s) Eudravigilance Clinical Trial Module (EVCTM).

All SUSARs submitted via the Eudravigilance system and processed before 11:00pm on 31 December 2020 will be passed to the MHRA. SUSAR submissions made after this point will need to be reported using the new routes.

The MHRA intends to publish a list of cases received on 31 December 2020 from the EMA and this list will be made available in January 2021 to assist sponsors with reconciliation.

DSURs and Annual Progress Reports will need to be submitted to the MHRA using MHRA Submissions via the Human Medicines option. Companies will need to select ‘Development Safety Update Report’ as the Regulatory Activity and ‘Original Submission’ from the Regulatory sub activity dropdown list. Acknowledgements of receipt for DSUR submissions generated by MHRA Submissions will be emailed to the reporter.

For detailed information, click here.