MHRA Strategy 2030 promises 14-day reviews for first human trials

The UK's medicines regulator has promised to assess first-in-human clinical trials within 14 days and to give a first assessment of new licensing applications within 90 days, backed by fee rebates if it misses those targets. The commitments are in MHRA Strategy 2030, published by the Medicines and Healthcare products Regulatory Agency (MHRA) on 14 October 2026.

The five-year strategy sets the agency's mission as "health and prosperity for all, through scientific excellence". It commits the MHRA to becoming what it calls a fast, expert and open regulator by 2030, and links its trial reforms to a government goal of moving the UK from fifth to third in the world for phase 1 clinical trials.

Service guarantees with rebates

The headline change is a set of service guarantees. The strategy promises an initial assessment of first-in-human trials within 14 days. First assessment of licensing applications and scientific opinions would each come within 90 days.

These guarantees come with a change to fees. The MHRA says fees "will change to support higher value services, with raised fees against performance guarantees relating to New Active Substances and Clinical Trial applications, and rebates in the rare cases where these standards are not met."

In other words, companies will pay more for these services and get money back if the MHRA is late. According to techUK's analysis of the strategy, the plan also includes a voucher scheme for small UK companies, so that higher fees do not shut out smaller developers.

Phase 1 trials as a growth target

The strategy says the UK government wants to make the country "a more attractive place to conduct research by simplifying processes, improving predictability and reducing clinical trial setup times."

To support the ambition of rising from 5th to 3rd globally for phase 1 trials by 2030, the MHRA commits to:

• a stepwise 14-day first review assessment for phase 1 clinical trials, with further improvements to timelines for the combined review it runs with the Health Research Authority (HRA)
• using AI to support review of documents, help sponsors answer requests for information and get trials "right first time"
• enabling a shift away from animal models towards human-relevant new approach methodologies (NAMs), such as organoids and organ-on-a-chip technologies

Phase 1 trials are usually the first time a new medicine is tested in people. Where they happen matters to a country's research economy, because later trials, investment and specialist jobs often follow.

Building on the April 2026 reforms

The strategy builds on the new UK clinical trials regulations that came into force on 28 April 2026. The strategy document lists features of those reforms alongside its new commitments. They include a 14-day assessment for phase 1 trials, further improvements to combined review timelines, and a notification scheme for low to moderate risk trials.

The MHRA reported on the first six months under those regulations in a blog published on 28 October 2026. We cover that in our article on the UK clinical trials regulations at six months.

AI checks before submission

Through its AI for Regulatory Insight, Safety and Efficiency (ARISE) programme, the MHRA says it is looking at where AI can safely automate tasks such as triaging applications, pre-screening evidence, identifying missing information, and highlighting potential grounds for non-acceptance.

As part of ARISE, the agency is building an AI-enabled Clinical Trial Protocol Checker. Sponsors will be able to test their protocols against common grounds for non-acceptance before they submit. The MHRA says this should reduce regulatory uncertainty and support "faster, higher-quality clinical trial applications."

The strategy says these tools will support human experts and will not replace them. The ARISE tools are funded by the Office for Life Sciences and the Regulators' Pioneer Fund.

New kinds of evidence

The strategy says new types of evidence need regulatory frameworks. It lists support for real-world data, in-silico evidence, and international data, including exploration of data from countries outside the OECD.

According to techUK's analysis, the MHRA commits to expanding its assessment of in-silico evidence, publishing guidance on digital twins, and enabling hybrid trials using digital twins and synthetic data. It also plans guidance on surrogate endpoints and novel statistical methods, and "prior knowledge platforms" so that developers can reuse core requirements for technologies such as antisense oligonucleotides, AAV gene therapy vectors, CAR-T cells and mRNA.

Rare diseases and inclusion

techUK's summary notes the strategy's statement that more than 3.5 million people in the UK live with a rare disease, and that only 5% of rare diseases have approved treatments. The MHRA says it will develop a more flexible framework for rare disease therapies through its Rare Disease Consortium, which includes patients, academics and industry.

On inclusion, the strategy acknowledges that many clinical studies "continue to underrepresent certain groups." It says the MHRA works with the HRA, the National Institute for Health and Care Research (NIHR) and others in the UK Clinical Research Delivery Group to improve inclusion. It will publish Areas of Regulatory Interest, including a new focus on women's health, to signal where better evidence is needed.

Faster patient access

The strategy repeatedly links approval to what happens next. The MHRA says it will work more closely with NICE "to shorten the time between approval and patient access", and will review the Innovative Licensing and Access Pathway (ILAP) with partners.

Clinical Trials Arena reported that the strategy also cuts the time for the MHRA's scientific advice service, with a lighter option aimed at 45 days, and speeds up decisions on generic and biosimilar medicines.

For companies, techUK reports, the MHRA plans a Customer Relationship Unit with optional "concierge" support and bookable submission slots, and a digital roadmap so that "companies will have real-time visibility of marketing authorisation application progress".

Safety and data

The strategy describes a move to continuous, real-time safety monitoring of medicines and devices over their whole lifecycle. It notes that linked hospital data and patient genomics are not yet routinely available for regulatory use, and says that "greater access to data must be matched by the capability to analyse it effectively."

How it compares

The MHRA is competing with other regulators for early-phase trials. In the US, the FDA opened applications on 15 September for an Expedited IND Pilot to speed up first-in-human trials, saying such trials can take up to two years in the US. We cover that in our article on the FDA Expedited IND Pilot.

In the EU, the FAST-EU pilot is testing multinational trial authorisation within 70 days, and the proposed Biotech Act would go further. See our article on the Biotech Act and CTIS.

What it means for patients

For patients, the strategy's promises are faster access to new treatments, more trials run in the UK, more inclusive research, and stronger safety monitoring. Faster phase 1 approvals could mean more early-stage trials open at UK hospitals, although these trials involve small numbers of people and the most uncertainty.

If you are thinking about taking part in a trial, our guide on how to find and join a clinical trial explains where UK trials are listed and what to ask. Our guide on how new medicines get approved explains the MHRA's role alongside NICE.

What happens next

The strategy runs to 2030. The MHRA says it will meet and, where possible, exceed its statutory targets over five years, supported by a performance framework and open reporting. Details of the new fees, rebates and the small company voucher scheme will need separate publication. The AI protocol checker is described as in development, with no launch date given.

Related reading

• UK clinical trials regulations at six months
• FDA launches Expedited IND Pilot under Operation TrialBlazer

This article is for general information and is not medical advice. Please talk to your own doctor before joining a trial or changing any treatment.