The MHRA’s new RegulatoryConnect portal and its first services are now available for customers to log in and use.
RegulatoryConnect is a new IT system being developed by the Medicines and Healthcare products Regulatory Agency (MHRA) to modernise its existing regulatory IT systems and make our regulatory services more streamlined.
The RegulatoryConnect portal will provide greater transparency and visibility for regulatory assessments.
Log in from today using your existing MHRA Submissions credentials to track the status of applications and view live authorisation details, including the status of, and key data held against your existing licences.
These services are available to those who have made applications to the MHRA on behalf of an 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.
Existing systems and services will not be turned off. You will still be able to access existing MHRA services in the same way and all applications will continue to be submitted through these systems until later releases.
How to use the RegulatoryConnect portal and preparing your organisation
Please follow the advice below when accessing RegulatoryConnect for the first time.
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For all users: To use RegulatoryConnect 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.
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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.
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For IT teams: as a new web application, the RegulatoryConnect portal may need to be approved for use at your organisation. The approval should only be required once per organisation.
How to provide feedback
RegulatoryConnect is built on principles of user centred design. Your experiences will help us to make changes to our services. Once you have accessed and used the portal and new services, tell us what you think by clicking on the BETA service feedback banner available on the portal.
How to get support with the new service
Guidance on how to get started, navigating the platform, and understanding application statuses is available here.
A contact form is available on the RegulatoryConnect portal and is available for support relating to the new service. The team that monitors the contact form will be unable to provide individual advice regarding timelines for specific applications.
The contact form should not be used for general MHRA queries and questions related to other systems and services, you should continue to use existing support channels for these.
What’s next for RegulatoryConnect
Future functionality and features will be added to RegulatoryConnect in later releases, including the ability to submit applications and variations to the MHRA through the service.
We recommend preparing your organisation by familiarising your staff with the RegulatoryConnect portal soon, so that you’re prepared to use future services when they arrive.
Thank you,
The Medicines and Healthcare products Regulatory Agency
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