Getting ready for the RegulatoryConnect portal: what you need to do

The MHRA’s new RegulatoryConnect portal and its first services will be available to customers from Monday 25 March 2024.

What is the RegulatoryConnect portal and what will it help me do?

The RegulatoryConnect portal will provide greater transparency and visibility for regulatory assessments. This first release will let you log-in using existing MHRA submission credentials and access a common portal, where you will be able to:

track the status of your application and see which stage it is at
view live authorisation details, including the status, key data and documents held against existing licences.

These services are available to those who have made applications to the MHRA on behalf of their organisation as an administrator or user. It will show the status of any pending submissions (excluding information updates and Periodic Safety Update Reports (PSURs)), and the latest granted submission for all live authorisations.

Accessing the RegulatoryConnect portal and getting your team ready

You will receive a link to the portal when it is launched on 25 March. There are a few things you can do to get you and your organisation ready to access the new services:

For all users: To use the RegulatoryConnect portal you must have an MHRA Submissions account, even if you do not use it for making submissions to the MHRA. Make sure that you have an MHRA Submissions account linked to your organisation. Information on how to do this is available here.
For account administrators: review the users that you have linked to your organisation in MHRA Submissions to ensure that the list is up to date. Instructions on how to do this can be found here.
For IT teams: as a new web application, the RegulatoryConnect portal may need to be approved for use at your organisation. It is likely that your organisation won’t be able to approve this until the portal is live and you have attempted log in. The approval should only be required once per organisation.

Existing systems and services will not be turned off. You will still be able to access the same MHRA services in the same way. All applications will continue to be submitted through these systems until later releases.

Guidance and support

The RegulatoryConnect portal is designed to be a user-friendly platform, and thorough guidance will be available to all users upon launch. Service support will also be available via the RegulatoryConnect portal.

Thank you,

The Medicines and Healthcare products Regulatory Agency

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