The Medicines and Healthcare products Regulatory Agency CEO Lawrence Tallon has presented evidence to a parliamentary inquiry on innovation in the NHS, focusing on personalised medicine and AI. Tallon explained measures to accelerate NHS adoption, made a number of predictions on “big changes” to follow the National Commission into the Regulation of AI in Healthcare, and put forward recommendations for UK government.
Tallon spoke on taking steps to closer align with NICE to ensure authorisation and reimbursement decisions can be made simultaneously, rather than sequentially, and to speed up the medicines approvals process by an estimated three-to-six months. He also noted the potential for AI to have an impact, stating: “Just like every other organisation and every other process; we’re all thinking about how AI can speed up our regulatory processes whilst maintaining or improving rigour.”
A more flexible approach is to be introduced later in 2026, Tallon continued, allowing developers to benefit from informal scientific advice to support them in testing ideas before approaching for formal advice. Due to the size of the US market, all product developers will almost always design for that market, he indicated, so “the more we can align with that market and the FDA; the more we will have earlier access to medicines and encourage product developers to bring R&D over to the UK knowing it is closely aligned with the US”.
Recently the MHRA has announced it will have a liaison office embedded in the FDA in Washington and vice versa, with Tallon calling this a “really significant development in regulatory affairs land”, pointing to the potential for earlier access to products, and the possibility for UK developers to take advantage of a faster route to the US market.
“The way that regulation has been set up historically in our agency and in other agencies has four underlying assumptions, all of which are going to be changed significantly by AI,” Tallon stated. “The first is that there is a very long development time, because bringing a medicine to market takes many years, but AI has a much faster development cycle.” Secondly, the barrier to entry for software as a medical device is lower than that for bringing medicines to market that can cost millions or even billions of pounds. Thirdly, medicine tends to be a static product that “does the same thing before and after being licensed”, whereas AI tends to change and evolve. “Finally, most medicines are developed around fairly high prevalence diseases, but increasingly we’re targeting medicines or software to smaller population diseases,” he added.
Tallon moved on to make three predictions for big changes following the National Commission into the Regulation of AI, including the need to better weigh risk of regulatory inaction with the risk of action. “It’s quite easy for a regulator to say, ‘if we approve this product and something happens, we can see the direct risk’, but increasingly, health systems need to be transformed and can be transformed with the use of technology, and we need to weigh the risk of holding that technology back, because at the moment our NHS is at risk of being behind the curve in terms of technology adoption compared to other advanced systems.”
The second likely change, according to Tallon, is a shift in emphasis to post-market surveillance, with software continuing to adapt, evolve, or drift, requiring multiple iterative checkpoints. “Third is context-specific regulation,” he went on, “needing to not only look at the product itself, but at the professional using that product and whether they understand it and its intended uses; the healthcare organisation and whether it can control for drift and change; the product developer looking at whether they will maintain their product responsibly post-market; and then the whole system.”
Moving forward, there is a need to be “very clear” on intended use and to monitor performance against that intended use, shared Tallon. “The risky thing is when products are used for purposes that are not part of the intended use; it may be that you find new intended uses, because you might find it’s really good at doing something you didn’t originally know; and then it will be going back through the licensing process to expand that intended use.” If regulators don’t enable technologies to come through, the danger is that they will be used anyway in an unregulated space, he considered.
Ultimately Tallon outlined recommendations that the MHRA should have the capacity to approve software as a medical device for the UK market; that investment should be made in the tech market to ensure the agency has the tech stack it needs; and that prices should be increased for a small number of “high value services” provided by the MHRA to developers.
Wider trend: MHRA regulation
The MHRA has announced plans to launch a regulatory AI sandbox with the aim to explore how AI can support medicines development and safety. The sandbox, funded by the Regulatory Innovation Office, will enable AI tools to be tested that have the potential to predict how medicines will be absorbed, processed, or whether they may cause harm. The sandbox will also be used to inform the MHRA about the reliability of whether AI tools can support in deciding the safety of new medicines. MHRA will use insights from the programme to evaluate the reliability of AI-enabled approaches, with this work expected to contribute to the development of a stronger evidence base and clearer guidance for the safe use of AI within medicines development.
The MHRA has launched a consultation on its proposals to extend existing transitional arrangements and continue to recognise medical devices approved in the EU “indefinitely”. The proposals put forward look to support the extension of measures put in place in 2023 to recognise CE marked medical devices on the British market to 2030, in a move the MHRA states is aimed at protecting patient access and ensuring continued supply of “safe and effective” medical technologies. Feedback is sought on three proposals: the proposal to extend transitional arrangements for devices certified under the EU Medical Device Directive (MDD); to continue to recognise EU MDR and EU IVDR compliant devices; and to introduce an international reliance route for higher risk CE marked devices.
The MHRA recently opened an offering to provide regulatory advice meetings on medical devices and in vitro diagnostic devices for manufacturers, at a cost of £987 for one hour. During the one hour meeting, the person or organisation requesting support is to begin with a short presentation outlining their questions and the “issues and controversies” surrounding them. The service aims to provide regulatory advice relating to medical devices, particularly if the application of existing regulatory guidance is not straightforward.
