MHRA lays out its thinking on AI and medicines regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a document explaining how its regulatory processes will adapt to the era of AI and personalised medicines, to the applause of the pharma industry.

In the new MHRA Strategy 2030 plan, the UK regulator has pledged to deliver faster and more predictable regulatory decisions, quicker access to new treatments, improved data connectivity, and a closer working relationship with the health technology assessment (HTA) agency NICE.

Overall, the aims are to make the NHS the world's most AI-enabled health system, improve patient care, and strengthen the UK's position as a global life sciences leader.

The document has been warmly welcomed by the Association of the British Pharmaceutical Industry (ABPI), which said it addresses several of its priorities for reforms to the regulatory environment for medicines in the UK.

"In 2024, our industry set out a clear ambition for the MHRA: to be among the best in the world at both regulating innovation and innovating regulation," said ABPI chief executive Richard Torbett. "This strategy matches that ambition and, in many areas, goes further."

Among the headline aspects of the strategy is a proposal to improve real-world evidence generation and regulation, assisted by AI, which the MHRA said will be one of the "defining medical technologies" of the coming years. The agency also intends to publish an AI Medicines Development Action Plan next year, laying out how AI can be used to transform medicines development.

Others include a commitment to halve the time it takes to deliver scientific advice to medicine and medical product developers, from 90 days to 45 days, to cut the initial assessment target for qualifying phase 1 clinical trials in half to 14 days, and to reduce the use of animals in testing.

There are also commitments to increase diversity in clinical trials, launch a women's health plan this year to secure better health outcomes for women, and to close health gaps between different ethnic groups.

"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 MHRA CEO Lawrence 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 plans come shortly after the UK government backed all the recommendations of a recently published report on using AI tools in the NHS, which found that the current regulatory framework for healthcare AIs is inadequate.