Public beta version (with guidance available)

The UK MHRA has launched RegulatoryConnect to track applications and view live authorization details. This fairly new portal, launched in March 2024 and still in beta, aims to enhance transparency for industry stakeholders.

Accessible via an MHRA Submissions account, RegulatoryConnect allows users to track application statuses and view key license data. MHRA provides guidance on using the portal and invites user feedback to improve the functionality of the portal.

It will replace existing portals, offering a single access point for regulatory activities.

Getting Started with RegulatoryConnect

The “Getting Started” guide for RegulatoryConnect outlines the process for accessing and using the portal.

To access RegulatoryConnect, users need an MHRA Submissions account linked to a registered organization, with login credentials from the MHRA Submissions portal. Users must ensure their account information is up to date, and that passwords are managed through their organization’s IT helpdesk. 

The Getting Started with RegulatoryConnect guide includes steps for logging in, such as entering the registered email and password, and accessing services on the welcome page after a successful login.

Troubleshooting advice addresses common issues like needing admin approval, initial authentication problems, non-existent users, and company data display errors, with detailed instructions for each scenario.

Accessing MHRA’s Regulatory Connect Portal

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 organization.

Account Administrators

Review the users that you have linked to your organization in MHRA Submissions to ensure that the list is up to date.

IT Teams

As a new web application, the RegulatoryConnect portal may need to be approved and/or validated for use at your organization. It is likely that your organization won’t be able to approve this until the portal is live and you have attempted to log in. The approval should only be required once per organization.

Navigating the RegulatoryConnect Portal

The “Navigating the RegulatoryConnect Portal” guide outlines the features and functionalities of the RegulatoryConnect portal. 

RegulatoryConnect portal provides transparency and visibility for regulatory assessments, allowing users to log in with existing MHRA credentials to track application statuses on the Applications page and view live authorization details on the Current Granted View page. Users can sort and filter application data and view key information and documents related to product and process licenses. 

The guide also details the use of the contact form for portal-related queries and emphasizes that it should not be used for general MHRA queries or assessment timeframes. Feedback on the portal can be submitted through a provided link, contributing to future improvements. 

Understanding Application Statuses of RegulatoryConnect

The document “MHRA RegulatoryConnect: Understanding application statuses” provides guidance on how to track and interpret the statuses of regulatory applications and authorizations via the RegulatoryConnect portal.

It categorizes submission statuses and authorization statuses with clear definitions for each. Key submission statuses include:

Authorization statuses include: 

Additionally, color cues are used for quick visual identification: 

The service updates data every 24 hours and tracks ongoing submissions from the validation stage.

Video Demonstration of RegulatoryConnect

According to the YouTube video demonstration, the RegulatoryConnect portal provides greater transparency and visibility for regulatory assessments and timelines, allowing users to log in with existing MHRA credentials to access two self-service tools: “Track My Case” and “Current Granted View.” 

The portal will eventually replace the Process Licencing Portal (PCL) and human medicines portals, enabling a single customer identity across all regulatory services. The welcome page details the status of applications and live authorizations, with filtering options for organizations, submission statuses, license types, and application types. 

Users can view high-level case information and key data held against licenses. Future releases will include license management and responses to regulatory inquiries. The portal also facilitates raising queries to the agency and providing feedback on services. Overall, these features enhance user engagement with the MHRA and provide a foundation for expanded functionality.

Portal Feaures

The first release will let users log in to the common portal using their existing submission credentials to access two self-serve services.

1. Tracking the status of application and see which stage it is at

2. Viewing live authorization details held against existing licenses, including: a) the status, b) key data and c) documents.

These two services will provide immediate benefits giving visibility over submissions but also it will form the foundation for longer term functionality in services and interactions with the agency more generally.

This is a foundation for what, in the long term, will become the front door for the agency other services will be brought onto the RegulatoryConnect, including a full end-to-end regulatory case life-cycle from submission through to assessment and then determination, as well as inspections and longer term also medical devices and import notifications.

This will replace the Process Licencing Portal (PCL) and the human medicines portal and longer term medical devices.

These features are available to those who have made applications to the MHRA on behalf of their organization as an administrator or user.

Application Status Tracking – Track My Case

RegulatoryConnect portal shows the status of any pending submissions (excluding information updates and Periodic Safety Update Reports), and the latest granted submission for all live authorizations.

Users see historic cases for all live authorizations. There is no cut off in terms of date. The user will see anything pending as well as the latest granted regulatory activity. Users can see all of the case numbers as well as the date that’s received and the submission status for those cases. 

Users can filter and sort the cases. Users can also see an expiration date of each of those statuses and see what those workflow steps mean and what subsequent workflow steps may be for that assessment. Users won’t be able to see detailed timelines for individual cases but this will provide an indication of where your case is within the overall regulatory life cycle in the assessment process.

Application Details page surfaces key high level information about the case including the submission status and the case number and the marketing authorization holder.Users can also see the application type, whether it’s a variation or an initial application. For example, you can see that a variation is an assessment but there is a live authorization status granted for the live license.

Product License Information – See My Data

See my data surfaces key data that’s held against the product license. It surfaces a subset of certification data for scope license types.

– Users are able to see key authorization details as well as details of the marketing authorization holder.

– Users also see details around formulation and packaging and substance details and excipients.

– Users can see key documents that are present.

– Users can view the summary of product characteristics (SmPC), the patient information leaflets as well as key labeling information held against the license. 

In future releases, the current granted view will also provide the users the ability to manage their license so that they can request license cancellation or apply a sunset clause or raise a variation directly from the license page.

Raising Queries

The portal will also provide the ability to raise any queries to the agency. MHRA is already stating that they are unable to provide specific timelines on individual applications and assessment processes this will provide the ability to get in touch with the MHRA for example if the users notice data inaccuracies ensuring that these are updated and are accurately reflected on their license. 

There is also a form for general feedback. On these Services, users can comment on how easy the service was to use as well as on guidance provided on the platform and whether ultimately the service adds value to their organization.

If you will be using the system, you should take advantage of the possibility to give feedback and ensure that the system will continue to improve.

To conclude

Potential users of RegulatoryConnect should ensure they have an MHRA Submissions account linked to their organization and verify their login credentials are up-to-date.

Initial errors may require IT or admin support. Users can track application statuses and view authorized product details.

Future updates of RegulatoryConnect should enable submission processes and license management, like cancellations and variations, directly through the portal, replacing existing MHRA portals for a seamless regulatory experience.