Welcome to the MHRA electronic reporting site for SUSARs

The eSUSAR website will be decommissioned 30 September 2022. Submissions after this date will not be received by the MHRA and your reporting obligations, as required by UK SI 2004/1031 (as amended), will not be met.

From 1 October 2022 SUSARs will only be accepted via Individual Case Safety Reports (ICSR) Submissions.

Current eSUSAR website users and new reporters (including Sponsors/CROs) are required to sign-up and begin submitting SUSARs via ICSR Submissions. Once registered, users must only use ICSR Submissions going forward, for submitting SUSAR reports.

Please note: we are no longer processing new requests for eSUSAR accounts.

Current users who already have an ICSR Submissions account , with immediate effect, must now solely use ICSR Submissions to submit SUSAR reports.

Please contact ICSRtesting@mhra.gov.uk if you require further assistance.

This site can be used to report Suspected Unexpected Serious Adverse Reactions (SUSARs) that have occurred during a clinical trial of a medicinal product.

The electronic SUSAR (eSUSAR) reporting form is available for use by all sponsors and institutions responsible for safety reporting in clinical trials. It aims to provide an easy to use method for electronic submission of SUSAR reports to the MHRA. In addition to this, the website can be used to maintain a record of reports that have been submitted for each of the institution's clinical trials.

Before using the eSUSAR website for the first time, institutions will need to register their details, together with those of a representative of the institution, with the MHRA. Click on the About link on the left of this page for further information on the registration process.

Further information and guidance regarding monitoring and pharmacovigilance in clinical trials can be found in Chapter II of EudraLex - Volume 10 Clinical trials guidelines.

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