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The UK Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) have today announced a new liaison programme, marking a significant step forward in strengthening the regulatory partnership between the UK and the US.
Speaking at the DIA Global Annual Meeting in Philadelphia, MHRA CEO Lawrence Tallon and FDA Deputy Commissioner Grace Graham announced the initiative to an audience of international regulators, industry leaders and experts focused on shaping the future of global healthcare regulation. The programme will establish dedicated, reciprocal liaison officer roles within each organisation.
The roles aim to enhance day-to-day collaboration, support scientific exchange and enable faster, more coordinated approaches to emerging regulatory challenges and decisions.
Building on the long-standing and trusted relationship, the initiative formalises and deepens cooperation between the two agencies across key focus areas including innovative medicines, medical devices, and emerging technologies such as AI.
By strengthening communication and sharing regulatory insight more effectively, the programme will help both organisations respond more quickly to advances in science and technology and support the development of safe, effective products for patients across both countries.
Importantly, both agencies will maintain full regulatory independence, while enabling closer alignment and collaboration where it delivers clear public health benefit. Whilst becoming increasingly aligned, both the MHRA and FDA will continue to make independent regulatory decisions.
Lawrence Tallon, MHRA Chief Executive, 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.
“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.
“It is a hugely exciting moment and a powerful signal of our shared ambition, to lead internationally, to innovate together, and to deliver for public health on a Transatlantic scale.”
Grace Graham, FDA Deputy Commissioner, said:
“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. We’re excited to launch this new initiative that will enhance institutional knowledge within the FDA and MHRA, improving the global oversight of drugs, biologics, and medical devices as we look to secure supply chains and ensure appropriate standards for clinical research.”
Today’s announcement follows the agency’s April commitment to deepen regulatory cooperation between the UK and the US on medical device regulation, with the new liaison roles supporting the wider US-UK pharmaceuticals partnership.
The liaison programme is designed to support closer working across technical, policy and scientific teams, creating new opportunities for joint initiatives, shared learning and coordinated approaches to complex regulatory issues.
The programme also reinforces the MHRA’s wider commitment to strengthening its principal international partnerships and shaping global standards, ensuring the UK remains a world leading destination for life sciences innovation.
As global health challenges and technological advances continue to evolve, the MHRA and FDA will utilise this programme to champion high standards, foster innovation and ultimately deliver better outcomes for patients.
Peter Ellingworth, CEO, the Association of British HealthTech Industries (ABHI), said:
“For HealthTech companies operating across global markets, greater alignment between trusted regulators reduces costs and complexity and supports more efficient routes to market. Closer cooperation between the MHRA and FDA is therefore a positive step towards a more connected regulatory environment.
“We welcome this commitment and look forward to seeing it translated into practical measures that support innovation, strengthen the UK’s attractiveness for investment, reduce friction for UK companies operating across global markets, and help patients on both sides of the Atlantic access life-saving and life-enhancing technologies more quickly.”
Scott Whitaker, President and CEO, AdvaMed, the Medtech Association, said:
“This collaboration between the FDA and MHRA reflects exactly the kind of forward-thinking regulatory leadership the medical technology industry needs. Closer alignment between these two agencies will reduce red tape, accelerate patient access to life-saving medtech on both sides of the Atlantic, and establish a strong model for how regulatory bodies can work together to keep pace with the remarkable speed at which our industry is innovating on behalf of patients.”
Duncan Edwards, CEO BritishAmerican Business said:
“Today’s announcement is a practical example of how the UK and US can work together to make it easier for innovative products to move between each other’s markets. 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.”
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