MHRA set to modernise patient-centred regulation 2030

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.

MHRA Chief Executive, Lawrence Tallon commented: “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 added: “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. This is an ambition we can only achieve by working together, and I would like to thank patients, healthcare professionals, the life sciences industry and our international counterparts for their continued collaboration and shared commitment to protecting the public.”

Contained in the 2030 Strategy are commitments from the MHRA to:

• Recruit specialised skills and expertise and use AI to analyse real world data and identify potential safety issues earlier.
• Work with the Health Data Research Service to use real-time surveillance to identify safety signals sooner and collect data on investigational medicinal products.
• Improve the collection and use of medical device data and enable precise identification and traceability of devices throughout their lifecycle.
• Make Yellow Card reporting of adverse events with medicines and medical devices simpler and quicker for patients and healthcare professionals.
• Make faster decisions on generic and biosimilar products so that patient access to these medicines and savings to the NHS can be made at the earliest opportunity.
• Increase diversity in clinical studies and launch a Women’s Health Plan this year to secure better health outcomes for women and to close health gaps between different ethnic groups.
• Strengthen patients’ contributions to regulatory decisions and publish a refreshed Patient and Public Involvement and Engagement Plan this year.
• Develop a more flexible and risk‑proportionate regulatory framework for rare disease therapies and better connect the UK’s genomics capability with the NHS and MHRA.
• Establish an MHRA Centre for AI and Digital Health to make clearer regulatory expectations for developers of digital and AI-driven medical devices and medicines.
• Create a modern, adaptive regulatory framework for AI as a medical device.
• Increase efficiency through international collaboration.