LONDON, June 15 -- The government of the United Kingdom issued the following news:
TheUKMedicines and Healthcare products Regulatory Agency(MHRA)and US Food and Drug Administration (FDA) havetodayannounceda new liaison programme, marking a significant step forward in strengthening the regulatory partnership between theUKand 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 willestablishdedicated, reciprocalliaison officer roleswithin each organisation.
Therolesaim toenhance day-to-day collaboration, support scientific exchange and enable faster, more coordinated approaches to emerging regulatory challengesand decisions.
Building onthelong-standing and trusted relationship, the initiative formalises and deepens cooperation between the two agencies acrosskey focusareas including innovative medicines, medical devices, and emerging technologies such asAI.
By strengthening communication and sharing regulatory insight more effectively, the programme will help both organisations respond more quickly to advances in scienceand technologyand support the development of safe, effective products for patientsacross both countries.
Importantly,bothagencieswillmaintainfull 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,MHRAChief Executive, said:
"By creating dedicated liaison roles, we are taking our collaboration to a new level,improvinghowwe shareexpertise, align onregulatoryscienceand technology, and respond to the pace of innovation.
"This will helpproduct developerscrossthe Atlantic, in both directions, because ourregulatorydecisionswill become more closely aligned, reducing friction to market from the UK to the US and viceversa.
"It is ahugely exciting moment and apowerful signal of our shared ambition, to lead internationally, to innovate together, and to deliver for public health on aTransatlanticscale."
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'reexcited 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 ensureappropriate standardsfor clinical research."
Today's announcement follows theagency's April commitmentto 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, sharedlearningand coordinated approaches to complex regulatory issues.
The programmealso reinforces the MHRA'swidercommitment to strengtheningits principalinternational partnerships and shaping global standards,ensuring the UKremainsaworldleading destination for life sciences innovation.
As global health challenges and technological advances continue to evolve, the MHRA and FDA willutilise thisprogramme tochampionhigh standards, foster innovation andultimately deliverbetter outcomesfor patients.
Peter Ellingworth,CEO,the Association of British HealthTech Industries (ABHI),said:
"For HealthTech companiesoperatingacross 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 accesslife-savingand life-enhancing technologies more quickly."
Scott Whitaker,PresidentandCEO,AdvaMed, the Medtech Association,said:
"Thiscollaboration 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 pacewith the remarkable speed at which our industry is innovating on behalf of patients."
Duncan Edwards,CEOBritishAmericanBusiness 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."
Notes to editors:
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Job descriptions, adverts, and eligibility criteriawill be publishedin due course.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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The US Food and Drug Administration (FDA)is responsible forprotecting public health in the United States by ensuring the safety, efficacy and security of human and veterinary medicines, biological products, and medical devices.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
Disclaimer: Curated by HT Syndication.