The UK Medicines and Healthcare products Regulatory Agency (MHRA) will ‘deepen’ collaboration with the US Food and Drug Administration (FDA) on medical technologies and AI to ‘harmonise’ regulation, it has been announced.
The aim is to drive innovation, accelerate patient access to the latest technologies, and reduce transatlantic barriers to market access, the MHRA has said.
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Speaking at the Advanced Medical Technology Association conference in San Diego last week, MHRA chief executive Lawrence Tallon highlighted the agency’s ‘strong partnership’ with the FDA.
He said: ‘We continue to work in close collaboration and are taking steps forward in the relationship between FDA and MHRA to strengthen regulatory alignment and reciprocity. We share an ambition to accelerate joint initiatives, enhance policy development, and identify and work together on strategic opportunities more effectively.’
He also drew parallels between Great Britain’s new medtech regulatory reforms – which will require medical device manufacturers to monitor the safety and performance of their products once on the market – with the FDA’s Total Product Life Cycle Advisory Programme (TAP).
‘The US and UK share a common goal – ensuring patients benefit quickly and safely from the latest medical innovations. With US-based thought leadership inputting to our new national AI commission, and new reliance frameworks for FDA approvals, we are laying the foundations for a truly global, innovation-ready regulatory environment,’ added Mr Tallon.
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The MHRA’s new National Commission on the Regulation of AI in Healthcare will bring together experts across the UK and internationally, including US experts Brian Anderson from the Coalition for Health AI/CHAI and Barry Stein, founder of the Center for AI Innovation in Healthcare.
The commission will influence recommendations on regulating AI-driven medical technologies, improving safe access to AI in healthcare and across the UK’s NHS.
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The MHRA confirmed that planned international reliance routes will allow medical devices approved by trusted regulators, including the FDA, to gain faster access to the UK market.
Also this month, the MHRA have announced that pharmaceutical companies developing qualifying medicines can now apply for early access to the UK’s new aligned regulatory pathway, six months ahead of schedule.
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