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 …
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 …
The refreshed Innovative Licensing and Access Pathway (ILAP) is setting a new global benchmark for accelerating patient access to transformative medicines in the UK. More than just a regulatory pathway, the ILAP is the first end-to-end access pathway that brings …
Well, hello again. Hasn’t time passed by so quickly since my last blog in September. At the MHRA, we have many exciting and pioneering initiatives underway. I was listening to a medical device podcast recently and the podcast host proclaimed …
When I think of adventurers and explorers, space exploration comes to mind. The courage to step into the unknown, to test the limits of what’s possible, and to bring back knowledge that advances the understanding of the collective. Regulation isn’t …
In six months’ time, on 28 April 2026, the most significant update to UK clinical trials regulations in two decades will come into force. This will be a pivotal moment for the evolving clinical trial landscape and marks a new …
September 2025: This blog provides information about the Route B substantial modifications and why you should sign up to take part in the pilot if you are eligible. We developed new clinical trial legislation in collaboration with the Health Research …
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