The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to deepen its collaboration with the US Food and Drug Administration (FDA) to enhance patient access to innovative medical technologies.
MHRA chief executive Lawrence Tallon outlined joint initiatives between the two agencies during a fireside chat with Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, at the Advanced Medical Technology Association (AdvaMed) conference in San Diego, US.
Among the key developments is a move towards greater regulatory alignment between the two agencies. Under the MHRA’s proposed new framework, international reliance routes will be introduced, allowing medical devices approved by trusted overseas regulators to gain faster and more efficient access to the UK market.
While initially focused on products authorised by the FDA, the MHRA confirmed that these routes could later extend to devices approved by regulators in Australia, Canada and other comparable markets.
The UK’s new medical technology regulations are expected to come into force in 2026, with the reliance routes anticipated to launch the following year.
Tallon said: “We continue to work in close collaboration, and are taking steps forward in the relationship between the FDA and MHRA to strengthen regulatory alignment and reciprocity. We share an ambition to accelerate joint initiatives, enhance policy development, and identify and work together on strategic opportunities more effectively.”
As part of this broader effort, the MHRA will also draw on input from US experts through the National Commission on the Regulation of AI in Healthcare, launched in September. The Commission aims to accelerate the safe and effective adoption of AI technologies across the NHS and to inform regulatory recommendations for AI-enabled medical devices.
US contributors include Brian Anderson, CEO of the Coalition for Health AI, and Barry Stein, founder of the Center for AI Innovation in Healthcare, alongside representatives from leading technology firms such as Google and Microsoft.
“The US and UK share a common goal – ensuring patients benefit quickly and safely from the latest medical innovations. With US-based thought leadership inputting to our new National AI Commission, and new reliance frameworks for FDA approvals, we are laying the foundations for a truly global, innovation-ready regulatory environment,” Tallon added.