The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2030 strategy, which aims to modernise patient-centred regulation for the era of AI and personalised medicines.
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 MHRA has committed to lead real‑world evidence generation and regulation. This includes enhancing access to real-world data from hospitals and genomics and recruiting specialised skills and expertise and using AI to analyse real world data and identify potential safety issues earlier.
The MHRA has also promised to deliver operational excellence by cutting by half the initial assessment target for qualifying Phase 1 clinical trials to 14 days and making 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.
Other commitments include providing patient-centred regulation; tackling the trade in illegal medicines; supporting innovation in life sciences; transforming regulation with AI and pioneer MedTech methodologies; and increasing efficiency through international collaboration.
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.
"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."
