MHRA 2030 strategy halves Phase 1 trial review target and plans AI protocol checker

The Medicines and Healthcare products Regulatory Agency (MHRA) published its 2030 Strategy on 14 October 2026, setting out how it will regulate medicines and medical devices across the UK for the rest of the decade ¹. The Association of the British Pharmaceutical Industry (ABPI) backed the plan on the same day ².

What the strategy commits to

The headline commitments for drug developers are about speed. The MHRA will introduce a new, higher value service option that fast-tracks scientific advice from 90 days to 45 days ¹. It will halve its initial assessment target for qualifying Phase 1 clinical trials to 14 days, and it promises faster decisions on generic and biosimilar products so that the NHS can capture savings sooner ¹.

AI runs through the operational plans as well as the products the agency oversees ¹. The MHRA says it will build an AI-enabled Clinical Trial Protocol Checker to give sponsors regulatory certainty and support faster, better trial applications, and will publish an AI Medicines Development Action Plan in 2027 on how AI will be used in medicines development ¹. It will also set up an MHRA Centre for AI and Digital Health to clarify what it expects from developers of AI-driven devices and medicines, and create an adaptive regulatory framework for AI as a medical device ¹.

On safety and evidence, the agency plans wider access to real-world data from hospitals and genomics, and will use AI to analyse that data so potential safety issues are spotted earlier ¹. It will work with the Health Data Research Service on real-time surveillance of safety signals, including for investigational medicinal products, and wants Yellow Card adverse event reporting to become simpler ¹.

Other commitments touch the early pipeline and smaller sponsors. The MHRA intends to support a move away from animal models towards human-relevant new approach methodologies such as organoids, offer a targeted voucher scheme to cut regulatory barriers for UK start-ups and smaller companies, and develop a more flexible, risk-proportionate framework for rare disease therapies ¹. Internationally, it will widen reliance and recognition routes with trusted regulators, including collaboration with the US FDA and continued recognition of CE-marked devices, and will chair the Access Consortium of Australia, Canada, Singapore, Switzerland and the UK ¹.

What it means for the market

For sponsors choosing where to run early studies, a 14-day initial assessment target for qualifying Phase 1 trials and a 45-day advice route are concrete service levels they can plan against, although the fast-track advice is described as a higher value option rather than the standard service ¹. The Health Research Authority's chief executive, Dr Matt Westmore, said the two bodies had delivered "the largest overhaul of clinical trials legislation for a generation" in the past 12 months, and that their processes are being aligned from application to patient enrolment ¹.

Generic and biosimilar makers stand to gain from quicker decisions, which the MHRA explicitly links to earlier savings for the NHS ¹. Developers of AI products get a dedicated centre and a promised framework, but the detail of how AI will be used in medicines development waits for the 2027 action plan ¹.

Industry reaction was positive. ABPI chief executive Richard Torbett said the strategy is "clear on speed, clear on standards and clear on how performance will be measured", and pointed to firm service guarantees and closer working with NICE ². The ABPI said the plan answers priorities it set out in a December 2024 report, including more predictable decisions and clearer performance reporting ². Minister for Health Innovation James Frith tied the strategy to faster patient access and to a crackdown on illegal medicines, where the MHRA plans a substantial increase in criminal enforcement capacity ¹.

Caveats

The strategy is a set of commitments, not delivered performance. The press release gives targets but no dates for most of them, and no budget or staffing figures for the new AI centre or the enforcement expansion ¹. Torbett said the industry body now wants to work with the MHRA on turning ambition into delivery ². The firmest near-term markers are a Women's Health Plan and a refreshed Patient and Public Involvement and Engagement Plan, both due this year, followed by the AI Medicines Development Action Plan in 2027 ¹.