UK changes SUSAR Reporting for IMPs

The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions, providing users "a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational Medicinal Products" (IMPs). The eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September 2022 and only SUSARS via the ICSR Submissions portal will be accepted from 1 October 2022.

Changes due to the Brexit

Following the Brexit, the ICSR Submissions and MHRA Gateway were introduced to replace the European modalities of reporting SUSARs via Eudravigilance to the MHRA at the end of the transition period. However, the eSUSAR website still served to provide a route for submitting SUSARs to the agency for new users and as an interim way for Sponsors awaiting registration for the new UK submission routes.

Switching over to ICSR Submissions enables eSUSAR users to report in accordance with ICH E2B required data elements. ICSR Submissions also has the capability to upload and post previously submitted XML files to aid reporting efficiency. The MHRA databases will be updated soon and no longer support the receipt of incoming reports from the eSUSAR website.

Read more in the MHRA Inspectorate blog Decommission of eSUSAR at GOV.UK.