Patients in the UK are set to benefit from a strengthened partnership between the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA), as both regulators unveil new plans to accelerate access to cutting-edge medical technologies and artificial intelligence in healthcare.
Announced at the Advanced Medical Technology Association (AdvaMed) conference in San Diego, MHRA Chief Executive Lawrence Tallon outlined the agency’s commitment to deepening ties with the FDA and driving global regulatory harmonisation.
Tallon said: “We continue to work in close collaboration, and are taking steps forward in the relationship between 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.”
The MHRA also launched its National AI Commission, bringing together UK and US experts to shape the safe and transparent use of AI in healthcare. The initiative is part of wider reforms aimed at improving patient safety and reducing barriers to market access for innovative technologies.
Tallon explained: “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.”
The collaboration includes new international reliance routes, allowing the UK to benefit from medical devices already approved by trusted regulators such as the FDA.
These efforts mirror the FDA’s Total Product Life Cycle Advisory Program (TAP), with both agencies exploring deeper transatlantic cooperation to support earlier and safer access to medical advances.
