Key Summary
- This initiative was announced by MHRA CEO Lawrence Tallon and FDA Deputy Commissioner Grace Graham during a Drug Information Association (DIA) meeting in Philadelphia.
- The liaison programme will support scientific exchange and enable faster, more coordinated approaches to emerging regulatory challenges and decisions.
- The programme will help both organisations respond more quickly to advances in science and technology
The medicine regulators of the UK and the United States have decided to increase collaboration and jointly deal with regulatory challenges.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) and US Food and Drug Administration (FDA) on Monday (15) announced a new liaison programme to strengthen the regulatory partnership between the two countries.
This initiative was announced by MHRA CEO Lawrence Tallon and FDA Deputy Commissioner Grace Graham during a Drug Information Association (DIA) global annual meeting in Philadelphia.
The meeting was attended by international regulators, industry leaders and experts, and 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.
The initiative also formalises and deepens cooperation between the two agencies across key focus areas, including innovative medicines, medical devices, and emerging technologies such as AI.
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.
However, both agencies will continue to maintain full regulatory independence and make independent regulatory decisions.
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.
“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.”
Graham 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.”
This 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.
Welcoming the move, the CEO of the Association of British HealthTech Industries (ABHI), Peter Ellingworth, 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."
