RegulatoryConnect
Source: gov.uk (2025-11-05)

The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.

Update on RegulatoryConnect – November 2025

Following a comprehensive review, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that it is closing the RegulatoryConnect (regulatory management system) programme. The programme will wind down over the coming months with work to determine a replacement that is aligned with the agency’s forthcoming new strategy.

The programme no longer offers value for money for UK taxpayers and the cost to complete the programme is too high for a solution which does not now enable us to deliver the aspirations of the agency.

The functionality to track applications and view live authorisation details through the existing portal will remain available.

Agency business continues uninterrupted, and performance remains strong. The MHRA’s ambition is to improve access to safe medicines and devices for UK patients, and support growth in the UK life sciences sector. Future technological solutions will ensure the agency is best placed to deliver.

The MHRA is currently developing a new multi-year strategy that will define our direction, mission, values and focus through to 2030. This strategy will be launched in early 2026 and at this point the technological needs of the agency will be revisited to ensure they support our revised strategic goals. This provides the opportunity to embed principles of risk proportionate regulation, data and intelligence, and to harness the opportunity of Artificial Intelligence (AI).

Further updates will be provided to stakeholders in the coming weeks.

RegulatoryConnect will make it easier for industry to see and track their regulatory assessments.

Users will sign in to the RegulatoryConnect portal (https://regulatoryconnect.mhra.gov.uk/) with their existing MHRA submission credentials to access two core services:
- Applications – track the progress of an application and see which stage it is at
- Current Granted View – see live licence details, including status, key data and documents linked to existing authorisations
These services are available to people submitting applications to the MHRA on behalf of their organisation, whether as an administrator or a user.

Over time, more features will be added to RegulatoryConnect. This will include the ability to submit applications and variations directly through the service.

RegulatoryConnect guidance

You can use the following guides to help you get started with the RegulatoryConnect portal:
- RegulatoryConnect: Getting started (https://assets.publishing.service.gov.uk/media/65fc55b8a6c0f7001aef91ee/RegulatoryConnect_-_Getting_started.pdf) (PDF, 746 KB, 11 pages)
- RegulatoryConnect: Navigating the RegulatoryConnect portal (https://assets.publishing.service.gov.uk/media/65fc55b8a6c0f70011ef91db/RegulatoryConnect_-_Navigating_the_RegulatoryConnect_portal.pdf) (PDF, 597 KB, 9 pages)
- RegulatoryConnect: Understanding application statuses (https://assets.publishing.service.gov.uk/media/65fc55b865ca2f00117da815/RegulatoryConnect_-_Understanding_application_statuses.pdf) (PDF, 366 KB, 7 pages)
- Watch a video demonstration of the RegulatoryConnect portal (https://www.youtube.com/watch?v=w1CSc2R-Gns&ab_channel=MHRAgovuk).
Webinars

Register (https://www.gov.uk/email/subscriptions/single-page/new?topic_id=regulatoryconnect) to receive email updates about upcoming sessions.

Past webinars

RegulatoryConnect 22 May 2025 (https://www.youtube.com/watch?v=QPFgKu098Ug)