MHRA regulatory innovation for developers

Key points

The MHRA’s role is shifting from approving products to orchestrating the system around them. Because much of that system is still being built, developers who engage early can help shape the rules their products will be judged against.

The foundations are now in place. The MHRA met or exceeded every statutory target in 2025/26, study set-up times fell from 169 to 122 days, and new laws on decentralised manufacture, device post-market surveillance and clinical trials are all in force.

Four enablers are being built in sequence: horizon scanning (the least developed), regulatory science capacity (the current bottleneck), sandboxes (advancing fastest) and scale-up and commercialisation (where the gap is widest).

International alignment is becoming practical. The MHRA–FDA liaison programme, the UK–Singapore Regulatory Innovation Corridor and the adoption of ICH M15 mean one evidence package can increasingly serve several regulators.

For developers, the advice is to engage before you have an application, treat sandboxes as a source of evidence that outlasts the pilot, and plan UK submissions alongside a second regulator.

Early engagement costs SMEs and mid-caps time they rarely budget for, with a payoff two to three years later, but is an investment that minimises slow adoption risks at launch.

The Medicines and Healthcare products Regulatory Agency (MHRA) is regulating technologies that the NHS is not yet equipped to deliver, from point-of-care manufacturing to AI now being tested in live NHS sandboxes, whilst also working with the Food and Drug Administration (FDA), Singapore and other global regulators for one evidence package to multiple markets. Its role is shifting from approving products to orchestrating the system around them, and because much of that system is still being built, developers who engage early have a real chance to shape the rules their products will later be judged against.

That was the message from James Pound, Interim Executive Director of Innovation and Compliance at the MHRA, when he set out the agency’s thinking on MHRA regulatory innovation at the 21 September EMIG Quarterly meeting. He was careful to present it as work in progress rather than settled policy, and that caveat is worth keeping. The direction, though, is already legible in what has been legislated and launched over the past 18 months.

Our assessment is that a UK marketing authorisation is no longer the product of a single agency acting in isolation. It is the output of a distributed system comprising the MHRA, the HTA bodies, NHS England and the devolved administrations, academic regulatory science centres, and an increasingly formalised set of bilateral relationships with the FDA, Singapore’s Health Sciences Authority and other national regulators. For mid-cap developers operating across the UK and Europe, this alters both the set of counterparties requiring engagement and the point in development at which that engagement must begin.

MHRA internal readiness for new regulatory challenges

Two conditions were critical to delivering on this vision, and both now hold:

Demonstrable operational performance. After acknowledged deficiencies in trial approvals, licensing and inspections, the agency reports meeting or exceeding every statutory target in 2025/26 and closing the year in surplus, with study set-up times under combined safety and ethical review down from 169 to 122 days. Without that baseline of throughput and predictability, no regulator can credibly ask sponsors to commit development resource to novel pathways.
A statutory base already in force, not in consultation. Decentralised manufacture regulations, covering point of care and modular models, took effect on 23 July 2025; post-market surveillance requirements for devices in Great Britain on 16 June 2025; and the largest package of clinical trials reform in two decades on 28 April 2026, with a five-year MHRA strategy to 2030 to follow. Each is enacted law against which development programmes can be designed, rather than policy intent.

Exhibit 1. Consistent delivery came first: approval times are down and confidence in the regulator is up

Four enablers, still being built, and they run in sequence

1. Horizon scanning

Horizon scanning is the first and least developed enabler. The aim is for the MHRA to spot new types of technology early enough to its assessment framework without waiting for primary legislation. Decentralised manufacturing is the worked example: moving from scale-up to scale-out required the entire approval framework to change before any product could come through, and took around five years. No investment decision can wait that long.

2. Regulatory science capacity.

The second enabler, and currently the binding constraint. Internal capability remains small relative to the breadth of what the agency must now assess, and the build is under way rather than complete. The response is the Centres of Excellence in Regulatory Science and Innovation (CERSI) programme: seven pilot centres established in 2025 on one year of seed funding totalling £6.2m, jointly backed by the MHRA, the Office for Life Sciences, Innovate UK and the MRC. Coverage spans the lifecycle, from digital manufacturing at Strathclyde and in-silico science at Manchester to AI at Birmingham and Brunel and advanced therapies at the Cell and Gene Therapy Catapult. Phase two moves to programme funding of up to five years across four centres.

Digital twins show what that capacity is for. In October 2025 the MHRA expanded the team that assesses computer-simulated trial data, to help sponsors use in-silico evidence and reduce reliance on animal models. Guidance on non-animal data published in March 2026 goes further: by the end of 2026, a developer whose product was built without animal testing can have the non-clinical module of its marketing authorisation application reviewed in advance. The use of AI-generated digital twins as synthetic control arms, built from historical patient data to reduce the number of participants randomised to placebo, is less settled. The MHRA’s draft guideline on external control arms, published for consultation in May 2025, is open to real-world data comparators where a randomised control would be unethical or unfeasible, but explicitly excludes synthetic arms built from simulated patients. In parallel, the agency’s own real-world data service, the Clinical Practice Research Datalink (CPRD), is validating high-fidelity synthetic data for sample-size boosting and as external controls. Sponsors should treat a digital-twin comparator as a question for early scientific advice, not an assumed route.

3. Sandboxes

The third enabler, and the one advancing fastest, though every instance remains a pilot. These are defined, time-limited environments for testing products under direct regulatory supervision, spanning virtual simulation through to live deployment in the health service. The AI Airlock, for AI as a medical device and backed by the government’s Regulatory Innovation Office, completed its second phase in May 2026 across seven innovators, with DHSC committing £1.2m a year for three years to continue it. Two initiatives now push into live NHS settings: London Region I, announced on 10 June 2026 with NHS England and London’s Health Innovation Networks, covering controlled deployment of AI medical devices with up to 10 manufacturers in the first phase; and the Manchester Sandbox, launched in September 2026 with Manchester University NHS Foundation Trust, which evaluates technologies in day-to-day care. The Regulating for Growth Bill would go further, giving government powers to temporarily modify or disapply legislation so approved businesses can test in the live market under supervision. The prize is international: given UK market size, sandboxes that de-risk a product for other regulators as well as the MHRA are what would make the UK a credible first destination.

Exhibit 2. Regulatory sandboxes run on a spectrum, from simulation to live use with rules flexed

4. Scale-up and commercialisation.

Scale-up and commercialisation. The fourth enabler, and the one where the gap is widest. The UK’s research base is not in question; translation into commercial scale remains the acknowledged weakness, and the mechanisms intended to close that gap are still being tested. The Innovative Licensing and Access Pathway (ILAP), relaunched on 30 January 2025, brings the MHRA, NHS England, the devolved administrations and NICE, SMC and AWTTC into a single pathway, with a Target Development Profile aligning evidence generation, regulatory milestones and NHS planning. Where readiness barriers are product-specific (e.g., storage or patient support models), manufacturers are expected to lead on resolving them. ILAP will not be scaled to all products: the resource intensity across every organisation involved is significant, which is why it is reserved for genuinely innovative products meeting unmet need.

Exhibit 3. The MHRA innovation agenda runs as a sequence and is influenced by international partnerships

The dependency between them matters more than any one enabler. Horizon scanning feeds regulatory science; regulatory science feeds the sandboxes; and the sandboxes exist so that when a novel product arrives, the groundwork for adapting the rules is already laid. None of the four is complete, each is being built while in use, and the specification of all four is still open to influence. That is the case for engaging early: not merely to secure a place, but to shape the framework against which a product will later be assessed.

The international layer

The MHRA and FDA announced a liaison programme on 15 June 2026, establishing reciprocal liaison officer roles in each agency to support scientific exchange and faster coordinated responses on emerging questions. It builds on an April 2026 commitment to align medical device regulation and explore future mutual recognition mechanisms. With Singapore, the Regulatory Innovation Corridor launched on 12 December 2025 gives developers a coordinated fast-track to engage both regulators at once and seek joint early advice, reducing duplication. A refreshed memorandum of understanding followed, and almost 40 new active substances have now been approved through Access Consortium work-sharing. Engagement with India’s Central Drugs Standard Control Organisation (CDSCO) reflects the scale of that market and its manufacturing investment. The multilateral fora, the International Council for Harmonisation (ICH), the International Medical Device Regulators Forum (IMDRF), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International Pharmaceutical Regulators Programme (IPRP), include the FDA, EMA and MHRA together, and were described as the natural route to alignment when regulatory centres of gravity diverge. ICH M15, the first harmonised guideline on model-informed drug development, shows that route working. The MHRA sat on the drafting group, ICH adopted the guideline in January 2026, and the FDA and EMA implemented it in June and July 2026 respectively. MHRA assessors have described UK practice as aligned with M15, so a sponsor can plan one modelling and simulation package, including how the risk of each model is rated, against a single framework across all three agencies.

Exhibit 4. UK evidence is designed for recognition by international regulators

What this means for pharmaceutical and devices developers

Engage before you have an application. The clearest message of the session was that an early approach on a novel technology is the signal the regulator needs to start work, potentially simulating around a product or building a bespoke offer, well ahead of submission. A dedicated navigation team exists for exactly this. Companies that arrive at the point of filing have already forfeited the most valuable part of the offer.
Treat sandboxes and CERSIs as evidence infrastructure, not a one-off pilot. A place in a live NHS sandbox generates safety and outcomes data under regulator oversight, which is the evidence HTA bodies and commissioners will likely ask for later; evidence that outlast the pilot itself.
Sequence the UK against a second regulator deliberately. With the FDA liaison programme and the Singapore corridor both operating, the question is no longer whether to file in the UK first, but which pair of submissions can share one evidence package.

The trade-off for SME and mid-cap companies is significant. Engaging early and consistently with the MHRA, NICE and NHS partners takes up regulatory and medical affairs time that most resource plans don’t budget for, and the payoff typically comes two to three years later. On balance, it is still worth it. The alternative is discovering, only after authorisation and at the point of launch, that the NHS doesn’t have the infrastructure to adopt a new technology. At that stage, the enabling infrastructure has not been established, and access is delayed for patients.

As was noted in closing, much of this would have been a hard sell ten years ago. Scientific and technological change has since outpaced the frameworks built to assess it, and that pressure is global: regulators that do not adapt become the rate-limiting step between a viable product and the patients indicated for it. Adaptation on both sides, by the agency and by industry, is what converts regulatory innovation into earlier access.

CF’s Life Sciences team works with companies on UK access strategy, evidence generation and NHS partnership design. If you would like to discuss what this means for your pipeline, please get in touch.

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FAQs

How is the MHRA's role changing?

The MHRA is adapting from approving medicines and medical technologies to coordinating the wider system that gets them to patients. A UK marketing authorisation now depends on a network that includes the MHRA, HTA bodies, NHS England, the devolved administrations, academic regulatory science centres and partner regulators such as the FDA and Singapore’s Health Sciences Authority.

What are the four enablers of the MHRA's innovation agenda?

They are horizon scanning, regulatory science capacity, sandboxes, and scale-up and commercialisation. They run in sequence: horizon scanning spots new technologies, regulatory science builds the expertise to assess them, and sandboxes test them under supervision so the rules can adapt before a product arrives for approval.

What regulatory sandboxes are available in the UK?

The AI Airlock, for AI as a medical device, completed its second phase in May 2026 and has DHSC funding of £1.2m a year for three years. London Region I, announced in June 2026, and the Manchester Sandbox, launched in September 2026, go further by testing technologies in live NHS settings. The proposed Regulating for Growth Bill would allow government to temporarily modify legislation so approved businesses can test in the live market.

What is ILAP and which products is it for?

The Innovative Licensing and Access Pathway, relaunched in January 2025, brings the MHRA, NHS England, NICE and the devolved bodies into a single pathway, using a Target Development Profile to align evidence, regulatory milestones and NHS planning. It is reserved for genuinely innovative products that meet an unmet need, because it demands significant resource from every organisation involved.

When should developers engage with the MHRA?

Before they have an application. An early approach on a novel technology gives the MHRA time to prepare, for example by simulating around the product or building a tailored offer, and a dedicated navigation team exists for this. Companies that first make contact at the point of filing miss the most valuable part of what’s on offer.

About the authors

Ben Richardson

Ben Richardson is a Managing Partner at CF, leading Life Sciences and Data Innovation. With two decades of experience, he has worked with health systems and life sciences companies globally, focusing on strategy, transformation, and development. Ben has contributed to primary care, diabetes, cardiovascular, cancer, mental health, and population health management. Since 2014, he has helped CF become an award-winning healthcare company in management consulting and data services.

Dr Ioannis Katsoulis

Dr Ioannis Katsoulis is Director of Life Sciences at CF, where he works with pharmaceutical companies, trade associations, regulators HTA bodies and charities on UK market access, pricing and adoption of new treatments. He has spent over 14 years in global value and access consulting, drawing on health technology assessment, health economics and real-world evidence to help innovative medicines reach the patients who need them.

Dr Dorinda Hickey

Dr Dorinda Hickey is an Associate at CF, where she focuses on market access, pricing and reimbursement, health technology assessment and payer engagement for life sciences organisations and charities. She has over 15 years in market access consulting, most recently as Executive Director of OPEN Health’s Evidence and Access practice. Before that she spent 17 years in senior commercial roles at Novartis (formerly Sandoz UK). She brings both an industry and an NHS perspective to how new treatments reach patients.

About CF

CF is a leading consultancy dedicated to making an enduring impact on health and healthcare. We work with leaders and frontline teams to improve health, transform healthcare, embed life science innovation and boost growth through investment. With unmatched access to UK healthcare data and award-winning data science expertise, our team are a driving force for delivering positive and meaningful change.

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