GuidanceGuidance 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).
Published 18 December 2020
From:
Medicines and Healthcare products Regulatory Agency

New rules for January 2021
The UK has left the EU, and the transition period after Brexit comes to an end this year.

This page tells you what you’ll need to do from 1 January 2021. It will be updated if anything changes.

For current information, read: Clinical trials for medicines: manage your authorisation, report safety issues
You can also read about the transition period.
Contents
Reporting SUSARs using the new reporting routes
Registering for ICSR Submissions
Registering for MHRA Gateway
Reporting SUSARs using the eSUSAR website
Transition between reporting to EU and UK systems
Business Continuity Plan for MHRA Gateway and ICSR Submissions
Submitting Development Safety Update Reports (DSURs) to the MHRA
Contact us
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From 1st January 2021, you must submit SUSARs in Great Britain and in Northern Ireland to the MHRA in one of the following ways:

using the eSUSAR website
using the ICSR Submissions
using the MHRA Gateway
If you intend to submit SUSARs using one of the new reporting routes, you must register as soon as possible before 1 January 2021.

For trials ongoing in both the UK and in European member states dual reporting is needed. You will need to report each SUSAR to both the MHRA and to the European Medicines Agency’s (EMA’s) Eudravigilance Clinical Trial Module (EVCTM).

Reporting SUSARs using the new reporting routes
Sponsors and Contract Research Organisations (CROs) will need to register to either the ICSR Submissions or the MHRA Gateway to enable configuration of their systems before 1st January 2021 in order to submit SUSARs to the MHRA.

If you have already registered, you do not need to complete this process again.

In order to differentiate SUSAR reports from post-marketing ICSRs, the new reporting systems will enable sponsors and CROs to specify the type of report from a study and assign the study type as a clinical trial.

Registering for ICSR Submissions
The ICSR Submissions is a web reporting tool that will replace the EudraVigilance website (EVWEB). It mimics the same reporting processes by enabling users to complete the online reporting form with details of the SUSAR. It also has the functionality to allow users to upload files that were submitted via the Eudravigilance System. This by-passes the need to complete the form.

The ICSR Submissions route is used to submit single SUSAR reports. To submit SUSARs to the MHRA using this route, visit the ICSR Submissions portal to register. Select ‘Request company account’ and follow the step-by-step guide to gain access to ICSR Submissions in the reference guide Registration for ICSR Submissions.

The ICSR Submissions registration video demo also covers the end-to-end process for registering to use the ICSR Submissions to report SUSARs.

On receipt of your registration request, the MHRA will aim to complete your registration within 5 working days.

Registering for MHRA Gateway
The MHRA Gateway will replace the Eudravigilance Gateway and offers a direct, secure database-to-database transmission of SUSARs into the MHRA system. The MHRA Gateway route is used to submit bulk SUSAR reports.

In order to gain access to, and submit SUSARs via, the MHRA Gateway, you will first need to access and register with another portal called MHRA Submissions.

Registering to MHRA Submissions:
The reference guide Gaining Access to MHRA Submissions provides a step-by-step account of how to set up user access. Guidance on managing users of the portal is also available in the reference guide Managing users on MHRA Submissions.

Three video demos provide further information on the user access management process and user permissions for using MHRA Submissions.

The MHRA Gateway registration video demo covers the end-to-end process for registering to use the MHRA Gateway to report SUSARs.

Direct links to the MHRA Gateway and MHRA Submissions are only provided once reporters are registered.

Reporting SUSARs using the eSUSAR website
We will be retaining the availability of the eSUSAR website for sponsors and CROs who wish to continue reporting SUSARs using this route.

If you currently report SUSARs using the eSUSAR website there is no additional need to register to either the ICSR Submission or the MHRA Gateway to submit SUSARs.

The eSUSAR website route is used to submit single SUSAR reports.

Transition between reporting to EU and UK systems
SUSARs currently reported using either EVWEB or the Eudravigilance Gateway are transmitted to the MHRA via the EMA’s Eudravigilance system.

Sponsors and CROs should plan on the basis that all SUSARs submitted via the Eudravigilance system and processed before 11:00pm on 31 December 2020 will be passed to the MHRA. SUSAR submissions not processed before this point will have to be reported using the new submission routes.

To assist companies in any reconciliation required, the MHRA intends to publish a list of cases received on 31 December 2020 from the EMA. This list will be made available in January 2021.

Business Continuity Plan for MHRA Gateway and ICSR Submissions
The MHRA will communicate at the earliest opportunity the expectations required by sponsors, CROs, and the MHRA when the MHRA Gateway and ICSR Submissions are impacted by planned and unplanned downtime. Please refer to the Business Continuity Plan for further information

Submitting Development Safety Update Reports (DSURs) to the MHRA
From 1 January 2021 you will need to submit DSURs using MHRA Submissions – see the section regarding registration to this system if applicable.

DSURs and Annual Progress Reports (provided in lieu of a full DSUR) should be submitted to the MHRA using MHRA Submissions via the Human Medicines option. 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 are generated by MHRA Submissions where a confirmation is emailed to the reporter.

If you are a CRO submitting DSURs on behalf of a trial sponsor, you both need to register to MHRA Submissions. The sponsor should be able to ‘add new organisation with users’ or ‘add user’ for CROs to have access with administrative permissions to make submissions.

For further information refer to registering with MHRA Submissions.

For further information please see our guidance Webinars: preparing to make submissions to the MHRA from 1 January 2021.

Contact us
If you have any queries around setting up the gateway company administrator on MHRA Submissions then please email submissions@mhra.gov.uk.

If you have not received an acknowledgment within 48 hours of submitting a SUSAR, contact E2B.support@mhra.gov.uk, including information on the filename, message number and sender report ID, as well as attaching the XML file.

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. You can also email submissions@mhra.gov.uk with urgent questions.
Published 18 December 2020