← Back

UK MHRA · UK · 14 Oct 2026 · News & press

MHRA 2030 Strategy to modernise patient-centred regulation for the era of AI and personalised medicines

AI-generated summary

The MHRA published its 2030 Strategy outlining plans to modernise medicines and medical device regulation to support AI, personalised medicines, and faster patient access to treatments. The strategy commits to enhancing real-world evidence generation, reducing assessment timelines for clinical trials and scientific advice, increasing diversity in clinical studies with a Women's Health Plan, tackling illegal medicines, supporting innovation through reduced barriers for start-ups, and developing AI-enabled regulatory tools. The MHRA aims to be more patient-centred, maintain safety standards, and strengthen the UK's position in life sciences globally.

From UK MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has set out ambitious plans to translate cutting-edge scientific and technological innovation into better health outcomes for patients across all four nations of the UK, in its 2030 Strategy published today.

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. 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.

The strategy defines the MHRA’s mission to contribute to ‘health and prosperity for all, through scientific excellence’ and reaffirms its central purpose to protect patients, improve public health and enable faster access to innovation.

Minister for Health Innovation, James Frith said:

We want patients to benefit faster from the latest medicines and technologies, while maintaining the highest standards of safety.

This strategy will help the MHRA keep pace with the latest innovations in AI, data and medicine, while strengthening its ability to crack down on illegal medicines to keep the public safe.

This will put patients at the heart of regulation, whoever they are and wherever they live — with greater diversity in clinical studies and a Women’s Health Plan to secure better outcomes for women.

MHRA Chief Executive, Lawrence Tallon said:

We are in the midst of a period of extraordinary scientific and technological discovery, which is helping to reshape how diseases can be prevented, diagnosed and treated. AI is transforming both regulated products and how organisations are run. Cell and gene therapies are offering the possibility of long-lasting or curative treatments. Precision and personalised medicines are transforming the accuracy and effectiveness of treatments. Advanced diagnostics are driving earlier intervention and better outcomes for patients.

These ground-breaking developments challenge traditional regulatory models and require innovative approaches to evidence generation, clinical research design, manufacturing oversight and safety and surveillance. 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.

MHRA Chair, Professor Anthony Harnden said:

Our 2030 Strategy sets out our vision for how we will harness extraordinary scientific and technological advances to catalyse innovation in the life sciences and accelerate access to safe and effective treatments for patients.

Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗