Timeline Brexit pharmacovigilance

BREXIT affects to pharmacovigilance in Clinical Trials (CTTs)

Since June 2016, the United Kingdom has been engaged in an arduous process that has not yet been completed. A process that we all know as Brexit.

Over the last few months, we have talked about the possible regulatory and operational consequences on this blog. And today, we present the first part of these changes.

Quick look at Brexit history

How does BREXIT finally affect pharmacovigilance (PV) in the Clinical Trials?

The consequences of Brexit, as was known from the beginning, do not affect the responsibilities of marketing authorisation holders and clinical trial sponsors in relation to submissions to the Medicines and Healthcare products Regulatory Agency (MHRA), but they do affect the procedures used to carry out these notifications.

Brexit 1 step

Brext 2 step


First, The UK government published, On 31 December 2020, updated guidance on the derogations and amendments to the EU guidance on good pharmacovigilance practice that apply to UK marketing authorisations.

Secondly, The following portals for the reporting of Serious and Unexpected Adverse Reactions (SUSARs) occurring in CHMPs being developed within the UK become operational:

  • Individual Case Safety Report (ICSR) ICSR Submission web; it replaces the EudraVigilance website (EVWEB) used until now for individual notifications of SUSARs occurring. One of the functionalities to facilitate the process is that it allows users to upload files that have been submitted via EudraVigilance.
  • MHRA Gateway replaces EudraVigilance Gateway and ensures a direct and secure database-to-database transmission from SUSAR to the MHRA system is used to send reports of groups of RAGIs that have occurred.

The eSUSAR Gateway continues to function for both developers and CROs who already use this route for reporting RAGIs. 

It should be noted that the eSUSAR Gateway continues to function for both developers and CROs who already use this route for reporting RAGIs. So if you use this route you do not need to register in the ICSR Submissions or the MHRA Gateway to submit these individual notifications.

take a look Brexit tip

Brexit. 3 step

Thirdly,  Changes also apply to notification of other types of safety reports such as the DSUR. Therefore, It can no longer be submitted via the CESP portal, so will now be submitted via the MHRA submissions portal (via the Human Medicines Option).

Brexit. Final step

Finally, as already confirmed, the possibility for a sponsor to continue to rely on the collaboration of an organisation (such as a CRO) to which it delegates, among others, the notification tasks (third-party) is still envisaged and will continue to be possible. But there are some considerations to be taken into account, e.g. in terms of DSUR notification both (developer and CRO) must have access to MHRA submissions and the developer can manage the administrative permissions to make submissions.

This process involves many changes

Therefore, in terms of managing new platforms, access, notification processes that clinical trial sponsors and CROs need to be aware. Therefore, proper planning is essential as from 23:00 on 31 December 2020, all notifications should have been communicated using these new submission routes.

The process

At EXPERIOR we offer pharmacovigilance services both during the clinical research phase and in the post-authorisation phase.

Our pharmacovigilance department is made up of expert and highly qualified professionals who have in-depth knowledge of all areas related to the safety of medicinal products.

If you have any doubgt with this issue or you need to help whit Pharmacovigilance procedures, please don’t hesitate to contact us.
Check here for more info of our Department and services.

Thanks to Carlos Martínez Navarro (Pharmacovigilance Technician. EXPERIOR), to share with us his knowledge. 

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