Rob Reid, MHRA deputy director of innovation devices, at AI Airlock Connect, October 2025 As the end of 2025 rapidly approaches, I find myself searching out those articles and lists that reflect on key moments across the year. Whether it …
How to avoid delays when submitting clinical trial application assessments The UK's new clinical trial regulations came into force on 28 April 2026, introducing a more flexible and risk-proportionate approach to clinical trial assessment. Sponsors now submit a single clinical …
In the first of a series of new blog posts focused on compliance issues for medical devices, our Market Surveillance team describes how we will support digital mental health technology developers to understand and navigate the regulatory framework. Background The …
It is widely recognised that AI technologies have the potential to positively transform healthcare by improving patient outcomes, supporting clinical decision-making and helping health services work more efficiently. However, AI systems can behave differently once they move from controlled testing …
Do you need help navigating regulatory requirements for a medical device? In December 2025, we launched the new MHRA Regulatory Advice Service for medical devices, offering those developing and working with medical devices the opportunity to meet directly with the …
The MHRA was pleased to participate in a workshop on 29 June 2026, organised by the British Embassy in Berne, which brought together senior leaders from the biopharma and space sectors, academia, regulatory bodies and funding organisations across the UK …
The UK is taking steps to support the development and manufacture of innovative medicines in microgravity. Through collaborative work between the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Space Agency, the UK has published the first dedicated …
The Innovative Licensing and Access Pathway (ILAP) and the MHRA-NICE Aligned Pathway both support earlier patient access to safe and effective medicines but they serve different purposes and are accessed at different points in development. The ILAP provides early, coordinated …
The rapid evolution of artificial intelligence (AI) is transforming healthcare, offering new opportunities to improve patient outcomes, enhance clinical decision-making, and increase system efficiency. At the same time, it presents complex regulatory challenges that existing frameworks were not specifically designed …
As part of the shift towards a risk-proportionate regulatory framework, the MHRA’s Clinical Trials Unit ran a Route B substantial modifications pilot from 1 October 2025 to 31 March 2026 to test a new process to streamline the review of …
A new era for healthcare Artificial intelligence (AI) is ushering in a new era, with the potential to reshape the world as we know it. In healthcare, it’s already starting to have an impact. AI can support earlier diagnosis and …
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