MHRA announces strategy to streamline regulation in the AI era
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring continued patient-centered regulation in the era of emerging artificial intelligence (AI) and personalized medicine. The plan outlines commitments and steps the agency should take through 2030 to keep pace with rapid technological and scientific developments and bring safe and effective treatments to patients more quickly.
"Commitments made in the strategy will enable the regulator to keep pace with rapid advances in science, technology and personalised healthcare, to benefit patients, and position the UK as a leading place to develop, launch and use new medicines and technologies safely and effectively," said MHRA. "By 2030, the MHRA aims to be even more patient-centred, support patients having faster access to safe, effective treatments, and have more data-connectivity and global influence."
While scientific and technological discoveries are transforming products used to prevent, diagnose, and treat disease, MHRA CEO Lawrence Tallon singled out AI as a key driver, reshaping both product regulation and the operations of healthcare companies. Cell and gene therapies, personalized medicine, and advanced diagnostics are also advancing medical care, he added.
"These ground-breaking developments challenge traditional regulatory models and require innovative approaches to evidence generation, clinical research design, manufacturing oversight and safety and surveillance," said Tallon. "Our 2030 Strategy sets out how, working with our partners across health and life sciences, we will translate scientific and technological innovation into better health outcomes for people across all four nations of the UK."
The strategy lists several broad concepts and deliverables listed under them. For instance, MHRA said that by 20230 it wants to lead real-world data generation and regulation. To achieve this, it said it will enhance access to real-world data from hospitals and genomics data. Furthermore, it plans to recruit experts with specialized knowledge and skills and to use AI to analyze data and identify potential safety signals sooner.
MHRA said it also plans to significantly reduce review times for fast-track scientific advice from 90 days to 45 days, cut the timeline for qualifying Phase 1 trials by half to 14 days, and work to deliver decisions for generic and biosimilar products more quickly. The agency also aims to continue its work encouraging researchers to shift away from animal models toward new approach methodologies when feasible, and to create a more flexible and risk-proportionate regulatory framework for rare disease treatments.
Another key ambition laid out in the strategy is to transform regulations with AI and pioneer new medtech methodologies.
"By 2030, we aim to deliver a globally leading approach to regulating AI as a medical device," said MHRA. "This includes continuous monitoring of real-world performance, staged authorisation, expanded Predetermined Change Control Plans, exploration of foundation model Master Files and a whole-system approach to safe deployment.
"We will establish an MHRA Centre for AI and Digital Health to strengthen expertise and support developers," the agency added.
The agency said the MHRA Centre for AI and Digital Health will also clarify regulatory expectations for developers of digital and AI-driven medical devices and medicines. Furthermore, as part of its AI initiatives, MHRA said it plans to develop an AI-enabled Clinical Trial Protocol Checker to provide sponsors with greater regulatory certainty and enable faster clinical trial applications.
"A new AI-enabled Clinical Trial Protocol Checker will help sponsors identify common reasons for non-acceptance before submission," said the agency.
MHRA also emphasized its plan to improve efficiency by leveraging international collaboration. In recent years, the agency has been open about its limited resources and plans to leverage international reliance to bring products to the UK market more efficiently by considering products already authorized under comparable regulatory regimes.
MHRA said it will expand reliance and recognition routes with trusted regulators, including the US Food and Drug Administration (FDA), and will continue to recognize CE-marked devices. It also plans to engage with other national regulators through the Regulatory Innovation Corridors, participate in the Access Consortium, and establish an annual regulatory science conference to convene regulators and experts to reinforce its leadership in the regulatory field.
"As part of this reform, we will expand international reliance and recognition with trusted international regulators," said MHRA. "Building on the wider US-UK pharmaceutical partnership, we will work with the US FDA to explore mutual recognition for medical devices.
"Following our 2026 consultation, we are also considering indefinite recognition in Great Britain of devices compliant with the EU Medical Device Regulation and In Vitro Diagnostic Medical Devices Regulation," the agency added. "Greater international alignment will reduce unnecessary burden, support UK competitiveness and help innovative technologies reach patients faster."
MHRA said it will also continue to play a leading role in international medtech regulations by participating in organizations such as the International Medical Device Regulators Forum and the Health AI Global Regulatory Network, and by joining the Medical Device Single Audit Program.
