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From 90 days to 45: the medicines regulator's plan for the next four years

Qurexa Editorial Team14 October 20269 min read 0 0
From 90 days to 45: the medicines regulator's plan for the next four years

What happened

On 14 October 2026, the Medicines and Healthcare products Regulatory Agency published its 2030 Strategy. The MHRA decides whether a medicine or a medical device can be used in the UK. It is an executive agency of the Department of Health and Social Care. Almost nothing you collect from a pharmacy got there without its approval. The strategy sets out what the agency plans to do between now and 2030. Its stated mission is "health and prosperity for all, through scientific excellence". Two of the numbers in it are about time. The first is scientific advice. Before a company spends years and millions testing a new medicine, it can ask the MHRA for advice on its plans. That can take up to 90 days. The strategy promises a higher-value option that cuts the wait to 45 days. The second is Phase 1 clinical trials. A Phase 1 trial is the first time a new medicine is given to people. It is usually a small number of volunteers, and the main question is whether the medicine is safe. The MHRA wants to halve its initial assessment target for qualifying Phase 1 trials, down to 14 days. Other commitments come with dates attached. A Women's Health Plan is due in 2026, as is a refreshed Patient and Public Involvement and Engagement Plan. An AI Medicines Development Action Plan is due in 2027. A new MHRA Centre for AI and Digital Health is to be set up, along with a modern regulatory framework for AI used as a medical device. Lawrence Tallon, the MHRA's Chief Executive, said: "We are in the midst of a period of extraordinary scientific and technological discovery." He also said that "AI is transforming both regulated products and how organisations are run", and pointed to cell and gene therapies and precision medicines as things that do not fit traditional regulatory models. James Frith, the Minister for Health Innovation, said: "We want patients to benefit faster from the latest medicines and technologies" - without lowering safety standards. Professor Anthony Harnden, the MHRA's Chair, added a note about how much one agency can do alone. "This is an ambition we can only achieve by working together," he said.

Why this matters

Most people never think about the MHRA. That is rather the point of a regulator working well. But the agency sits at a gate that matters enormously. A new cancer medicine, a new insulin, an app that reads your heart trace: all of them have to get past the MHRA before a UK patient can use them. How long that takes is not an administrative detail. For someone with a condition that has no good treatment, it is the difference between waiting and not waiting. So the time targets are the part of this strategy that could reach ordinary people most directly. Faster advice and faster first assessments make the UK a more attractive place to run a trial. More trials in the UK means more UK patients with the option of joining one. A second thread is about whose bodies the evidence comes from. The MHRA says it wants to increase diversity in clinical trials and help close health gaps between ethnic groups. This sounds technical. It is not. If a medicine was mostly tested on one group of people, nobody can be fully confident how it behaves in another. The Women's Health Plan sits in the same space. A third thread is about watching medicines after they are approved. Approval is not the end of the story; it is the start of the real-world test, with millions of people instead of a few thousand volunteers. The strategy promises better access to hospital and genomic data, more use of AI to spot safety signals sooner, better tracing of medical devices, and a simpler Yellow Card process for reporting side effects. That last one is small and genuinely useful. Yellow Card is the UK scheme where anyone, including patients, can report a suspected side effect from a medicine or a problem with a device. It is one of the main ways a rare problem gets noticed at all. An easier process means more reports, and more reports means problems are found earlier.

What the evidence actually says

It is worth being clear about what kind of document this is. A strategy is a set of promises, not a set of results. Nothing in it has happened yet. What it does contain is dates, and dates can be checked later. Readers are entitled to hold the agency to them. What the strategy does not do is tell you when any of this reaches your own prescription. A faster Phase 1 assessment helps a medicine that is still years away from a pharmacy shelf. The gain is real, but slow and cumulative rather than dramatic. One claim is more concrete than the rest, and it comes from outside the MHRA. Dr Matt Westmore, Chief Executive of the Health Research Authority, described the past year's clinical trials legislation as the largest overhaul in a generation, and said the HRA and MHRA are also digitising the path from research application to patient enrolment. That is already under way rather than a target. Industry has welcomed the strategy, which is no surprise, though the reasons are specific. Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry, singled out commitments on speed, on standards, on measuring the agency's own performance, on working more closely with NICE, and on involving patients. That NICE point deserves a flag. The MHRA decides whether a medicine is safe and works. NICE decides whether the NHS should pay for it. A medicine can clear the first hurdle and stall at the second, which is why the two bodies working to the same clock matters more than it sounds. Internationally, the MHRA says it will expand reliance and recognition routes with regulators it trusts, including the US Food and Drug Administration, and will keep chairing the Access Consortium: Australia, Canada, Singapore, Switzerland and the UK. Sharing assessment work with trusted partners is one of the few ways to go faster without cutting corners.

Qurexa perspective

We deliver prescriptions and help people stay on top of their medicines, so two parts of this strategy land close to our day job. The first is Yellow Card. The people most likely to notice that something is wrong with a medicine are the people taking it every day, and their families. They are also the least likely to think reporting it is their place. It is. The system only sees what people tell it. The second is pace. If more new medicines arrive sooner, pharmacy teams are the ones who explain them, supply them and manage the switch from the old one. One honest caution. A strategy about speed can read as though caution is the problem. It is not. The reason UK approvals carry weight is the checking behind them. The right version of this plan is one where the checking stays and the waiting shrinks.

Practical advice

There is nothing here you need to act on today. But a few things are worth doing anyway. Report side effects. If you think a medicine has caused a problem, you can report it yourself through the Yellow Card scheme, online or through its app. You do not need to be certain the medicine was the cause. Suspicion is enough, and that is deliberate. Ask about trials if you have a condition that is not well controlled. Your GP or hospital team can tell you whether a study is recruiting that might suit you. Taking part is voluntary, and you can leave at any time. Buy medicines only from a registered source. A UK registered pharmacy, in person or online, is checked. A seller in a social media message is not. If a prescription-only medicine is offered without a prescription, that is the warning sign, not the price. Do not stop or change a medicine because of a news story, including this one. If something worries you, ring your pharmacy. That conversation is free and takes minutes.

What to know

The MHRA published its 2030 Strategy on 14 October 2026. It is a plan for how the UK will regulate medicines, medical devices and digital health technology over the next four years. The headline promises are faster timelines: scientific advice cut from 90 days to 45 through a higher-value option, and the initial assessment target for qualifying Phase 1 clinical trials halved to 14 days. A Women's Health Plan and a refreshed patient involvement plan are due in 2026. An AI Medicines Development Action Plan is due in 2027, alongside a new MHRA Centre for AI and Digital Health. Other commitments cover wider use of real-world hospital and genomic data, a simpler Yellow Card reporting process, more diverse clinical trials, expanded criminal enforcement against illegal medicines, a shift from animal testing towards human-relevant methods such as organoids, and expanded recognition of decisions by trusted regulators including the US FDA. None of it has happened yet. These are dated commitments, which means they can be checked. The things likely to reach patients soonest are the small, practical ones: an easier way to report a side effect, and a better chance of a trial running near you. Sources: GOV.UK / Medicines and Healthcare products Regulatory Agency, "MHRA 2030 Strategy to modernise patient-centred regulation for the era of AI and personalised medicines", 14 October 2026, https://www.gov.uk/government/news/mhra-2030-strategy-to-modernise-patient-centred-regulation-for-the-era-of-ai-and-personalised-medicines ; National Health Executive, "MHRA unveils ambitious strategy to accelerate innovation and improve patient outcomes", 14 October 2026, https://www.nationalhealthexecutive.com/articles/mhra-unveils-ambitious-strategy-accelerate-innovation-and-improve-patient-outcomes This article is for general information and does not replace advice from a doctor, pharmacist or other qualified healthcare professional. Do not start, stop or change any medicine on the basis of a news article. If you are worried about a medicine you are taking, speak to your pharmacist or GP.

#MHRA#medicines regulation#clinical trials#patient safety#Yellow Card#NHS

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