FDA and UK's MHRA to Embed Liaison Officers at Each Other's Headquarters

The US Food and Drug Administration and the UK's Medicines and Healthcare products Regulatory Agency will each embed a staff member at the other's headquarters under a new liaison programme announced on June 15, according to statements from the MHRA and the FDA.

Under the initiative, an FDA representative will be embedded at the MHRA's headquarters in London and an MHRA representative at the FDA's headquarters in White Oak, Maryland, the FDA said in a bulletin to international colleagues. FDA Deputy Commissioner for Policy, Legislation and International Affairs Grace Graham and MHRA Chief Executive Lawrence Tallon announced the programme during a session at the DIA Global Annual Meeting in Philadelphia.

Devices and AI among the focus areas

The MHRA said the dedicated, reciprocal liaison roles are meant to improve day-to-day collaboration, support scientific exchange and allow faster, more coordinated approaches to emerging regulatory challenges and decisions. It named innovative medicines, medical devices and emerging technologies such as AI as key focus areas. The FDA listed medical devices, artificial intelligence, rare diseases and real-world evidence and data as areas where it expects the embedded staff to help identify opportunities.

Both agencies will keep full regulatory independence, the MHRA said: "Whilst becoming increasingly aligned, both the MHRA and FDA will continue to make independent regulatory decisions."

"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," Tallon said in the MHRA statement.

Graham said in the same statement that aligning on regulatory science "can speed access to medical products and reduce time to markets both here and in the UK." She said the initiative would improve global oversight of drugs, biologics and medical devices "as we look to secure supply chains and ensure appropriate standards for clinical research."

Industry groups weigh in

The MHRA said the announcement follows an April commitment to deepen UK-US cooperation on medical device regulation, and that the liaison roles support the wider US-UK pharmaceuticals partnership.

Trade groups quoted by the MHRA welcomed the move. Peter Ellingworth, chief executive of the Association of British HealthTech Industries, said greater alignment between trusted regulators "reduces costs and complexity and supports more efficient routes to market," and that the group looked forward to seeing it translated into practical measures. Scott Whitaker, president and chief executive of AdvaMed, said closer alignment between the two agencies would "reduce red tape" and could establish a model for how regulators work together.

Neither agency gave a start date for the placements. The MHRA said job descriptions, adverts and eligibility criteria will be published in due course, and the FDA said it had posted a job announcement for its side of the exchange.