The MHRA and FDA have launched a reciprocal liaison programme, embedding staff within each agency to strengthen collaboration on medicines, medical devices, AI, rare diseases, and regulatory science.
Written By: Umesh Hanumante,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
The MHRA and FDA have established a new transatlantic liaison programme that formalizes and deepens regulatory collaboration between the United Kingdom and the United States. Announced during the DIA Global Annual Meeting in Philadelphia, the initiative will embed an FDA representative at the MHRA headquarters in London and an MHRA representative at the FDA’s White Oak, Maryland campus.
The programme introduces dedicated liaison roles to strengthen day-to-day engagement across scientific, technical, and policy functions. Both agencies expect the arrangement to accelerate joint initiatives, improve regulatory coordination, and support more efficient responses to emerging healthcare technologies and public health challenges.
Strengthening Regulatory Science Across Borders
The collaboration builds on a long-standing relationship between two of the world’s most influential healthcare regulators. It reflects growing recognition that advances in medicines, medical devices, digital health technologies, and artificial intelligence increasingly require coordinated regulatory approaches.
The FDA highlighted the UK’s advanced health data infrastructure, strong academic research base, and growing technology sector as key factors supporting scientific collaboration and regulatory innovation. The agencies expect the embedded staff model to enhance knowledge sharing and help identify strategic opportunities in areas including medical devices, artificial intelligence, rare diseases, and the use of real-world evidence and real-world data in regulatory decision-making.
Both organizations emphasized that the programme will not affect regulatory independence. While collaboration and alignment are expected to increase, each agency will continue to make its own regulatory decisions.
Reducing Friction for Product Developers
MHRA Chief Executive Lawrence Tallon said the new liaison roles elevate cooperation on regulatory science, technology, and policy development. He noted that closer engagement could help product developers navigate regulatory pathways more efficiently across both markets.
The initiative follows commitments announced earlier this year to strengthen UK-US cooperation in medical device regulation and supports broader pharmaceutical and life sciences collaboration between the two countries.
For companies developing medicines, biologics, medical devices, and AI-enabled technologies, greater regulatory consistency may reduce duplication, improve development planning, and streamline market access strategies on both sides of the Atlantic.
FDA Deputy Commissioner for Policy, Legislation and International Affairs Grace Graham said stronger alignment in regulatory science can help accelerate patient access to medical products while enhancing oversight of drugs, biologics, and medical devices.
Industry Welcomes Closer Cooperation
Industry groups welcomed the announcement as a practical step toward reducing regulatory complexity and improving predictability for global product developers.
Peter Ellingworth, Chief Executive of the Association of British HealthTech Industries (ABHI), said closer coordination between trusted regulators could lower costs, reduce market-entry barriers, and support faster patient access to innovative technologies.
Scott Whitaker, President and CEO of AdvaMed, said the initiative reflects the type of regulatory collaboration needed to keep pace with rapid advances in medical technology. Duncan Edwards, CEO of BritishAmerican Business, added that greater regulatory certainty can encourage investment, innovation, and cross-border growth.
Impact on Life Sciences Innovation
The liaison programme creates a framework for deeper collaboration across scientific, technical, and policy teams within both agencies. Future activities are expected to include joint projects, coordinated approaches to complex regulatory questions, and expanded regulatory science initiatives.
As healthcare innovation becomes increasingly global, the MHRA and FDA are positioning themselves to shape international regulatory standards while supporting the development and oversight of safe, effective medical products. The initiative also reinforces the UK’s ambition to remain a leading destination for life sciences innovation and strengthens one of the most significant regulatory partnerships in global healthcare.
Reference
Unique liaison programme set to reinforce close collaboration between MHRA and FDA – GOV.UK
About the Writer
Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.