# RegulatoryConnect

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/802428bd-9ee1-4216-b3a2-b9145f11f815
Type: Detailed Guide
Published: March 25, 2024
Updated: November 5, 2025

> In November 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the closure of its RegulatoryConnect management system programme. Following a comprehensive review, the agency concluded that the project no longer provides sufficient value for UK taxpayers and that the costs to complete it are too high relative to its expected utility. This decision aligns with the agency's upcoming strategic shift. Despite the programme's wind-down, the MHRA confirms that business operations remain uninterrupted and performance is stable. The existing portal functionality remains active, allowing industry stakeholders to track application progress and view live authorization details, such as license status and linked documentation, using current credentials. Looking ahead, the MHRA is developing a new multi-year strategy for launch in early 2026, which will define its mission through 2030. This future framework will prioritize risk-proportionate regulation, data-driven intelligence, and the integration of Artificial Intelligence (AI) to support the UK life sciences sector. While no immediate corrective actions are required from regulated entities, users are encouraged to utilize existing online guides and webinars for navigating the current portal. Further updates regarding the agency's technological direction and the new 2030 strategy are expected in the coming weeks.

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## Content

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 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 ( PDF , 746 KB , 11 pages ) RegulatoryConnect: Navigating the RegulatoryConnect portal ( PDF , 597 KB , 9 pages ) RegulatoryConnect: Understanding application statuses ( PDF , 366 KB , 7 pages ) Watch a video demonstration of the RegulatoryConnect portal . Webinars Register to receive email updates about upcoming sessions. Past webinars RegulatoryConnect 22 May 2025

## Attachments

- [RegulatoryConnect: Getting started](https://assets.publishing.service.gov.uk/media/65fc55b8a6c0f7001aef91ee/RegulatoryConnect_-_Getting_started.pdf)
- [RegulatoryConnect: Navigating the RegulatoryConnect portal](https://assets.publishing.service.gov.uk/media/65fc55b8a6c0f70011ef91db/RegulatoryConnect_-_Navigating_the_RegulatoryConnect_portal.pdf)
- [RegulatoryConnect: Understanding application statuses](https://assets.publishing.service.gov.uk/media/65fc55b865ca2f00117da815/RegulatoryConnect_-_Understanding_application_statuses.pdf)
