MHRA to Launch RegulatoryConnect Portal in the UK: A New Era in Regulatory Management

RegulatoryConnect: Simplifying Processes, Enhancing Transparency

RegulatoryConnect aims to simplify the regulatory process, offering key functionalities that promise to improve the efficiency and transparency of the MHRA’s services.

The portal will initially include features such as “ Track my case“, allowing users to see the progress of their applications, thereby aiming to significantly reduce the weekly enquiries currently received by the agency.

Users will also benefit from email notifications that provide updates on their submissions and the ability to view live authorisation details under “ See my data“, ensuring greater transparency and convenience.

These services, refreshed every 24 hours, mark just the beginning of what RegulatoryConnect plans to offer. Only applications currently under validation by the agency will be visible, but this is a step towards comprehensive access and interaction with the MHRA.

Parallel Developments and Future Enhancements

In addition to the launch of the RegulatoryConnect portal, the MHRA is also implementing parallel activities to further enhance the information available to agency staff and stakeholders.

This includes the introduction of a new eCTD software solution, revalidation of existing sequences in the agency’s archive, and improved data reporting capabilities through PowerBI for the GxP inspectorate.

The MHRA is also in the process of importing historical data from legacy systems, ensuring ongoing management and application of standardized terms and IDMP methodologies.

It’s important to note that application submissions will continue via MHRA Submissions until the release of RegulatoryConnect Release 2, expected before the end of 2024.

This next phase will introduce a UK-specific application form and replace the current portals for Product Licensing (PL) and Process Licensing (PCL) submissions.

Looking Ahead: Release 3 in 2025

The journey with RegulatoryConnect does not stop at Releases 1 & 2. The MHRA is already planning for Release 3 in 2025, which currently aims to implement features around submissions for the Early Access to Medicines Scheme (EAMS), Borderline products, the Import Notification Scheme for Unlicensed Medicines, Devices Registration, Approved Bodies and requests for Certificates of Free Sale.

The agency is also considering the timelines for the integration of additional services to enhance the portal’s scope. This includes exploring the inclusion of submissions for ILAP, IDAP, PIP, PSUR, eCigarettes, Windsor Framework, and Customer Service Centre enquiries in future releases.

While the use of RegulatoryConnect for submissions related to Clinical Trial Authorisations, Clinical Investigations, and Scientific Advice are under consideration as separate projects, these features are not planned for the initial releases.

The launch of Release 1 of RegulatoryConnect marks a significant milestone in the MHRA’s commitment to providing a single point of access for all interactions with the agency.

The MHRA is dedicated to continuously improving its services and supporting the needs of its stakeholders through this innovative portal.

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