The US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have announced a significant new liaison programme designed to deepen regulatory collaboration between the two agencies. The initiative, unveiled during the DIA Global Annual Meeting held from 14 to 18 June in Philadelphia, focuses on medical devices, artificial intelligence, and innovative medicines. By formalising their cooperative approach, both agencies aim to respond more swiftly to scientific and technological advances while supporting the development of safe and effective products for patients across both nations. Importantly, the programme preserves the full regulatory independence of each organisation.
A central feature of this FDA and MHRA regulatory collaboration is the appointment of reciprocal liaison officer roles embedded within both the FDA and the MHRA. These officers will be tasked with enhancing daily coordination, facilitating scientific exchange, and streamlining how both agencies tackle emerging regulatory challenges and decisions. MHRA CEO Lawrence Tallon said: “By creating dedicated liaison roles, we are taking our collaboration to a new level, improving how we share expertise, align on regulatory science and technology, and respond to the pace of innovation.” He added: “This will help product developers cross the Atlantic, in both directions, because our regulatory decisions will become more closely aligned, reducing friction to market from the UK to the US and vice versa.”
FDA deputy commissioner Grace Graham commented: “American patients and innovators benefit when regulators collaborate, as aligning on regulatory science can speed access to medical products and reduce time to markets both here and in the UK.” The liaison programme builds on a commitment made in April by both agencies to deepen cooperation on medical device regulation. Scott Whitaker, CEO of the Advanced Medical Technology Association (AdvaMed), responded to the initiative by highlighting that closer alignment between the agencies will reduce red tape and “accelerate patient access to lifesaving medtech on both sides of the Atlantic.”
The regulatory collaboration between the FDA and MHRA also follows the UK-US pharmaceutical trade and pricing agreement implemented in April 2026. That deal secured 0% tariffs on UK drug exports to the US, with the UK agreeing to raise the net price the NHS pays for new branded medicines by 25% in return. Duncan Edwards, CEO of BritishAmerican Business, said: “Building on the UK-US pharmaceutical agreement, it sends a positive signal to companies looking to invest, innovate and grow on both sides of the Atlantic. Businesses value certainty, and closer cooperation between regulators can help provide it.”
The liaison programme also arrives as the MHRA enters the final stages of developing a new AI regulatory framework intended to replace the medical device regulation that currently governs AI in healthcare in the UK. To shape this framework, the MHRA established the National Commission on the Regulation of AI in Healthcare. Final results from the policy-shaping consultation were published on 11 June. Of the 761 unique responses obtained from stakeholders, including NHS bodies, industry, and academia, 50% of respondents said the existing framework for AI needed substantial revision, while 21% called for a complete overhaul. Together, these developments underscore the growing momentum behind regulatory collaboration aimed at keeping pace with innovation in medical devices, innovative medicines, and artificial intelligence across both markets.
