MHRA reveals 2030 Strategy to modernise patient-centred regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2030 Strategy, setting out ambitious plans to translate scientific and technological innovation into better health outcomes. The regulator says that the commitments will enable it 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. 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. “These ground-breaking developments challenge traditional regulatory models and require innovative approaches to evidence generation, clinical research design, manufacturing oversight and safety and surveillance.” Building on progress In the 2030 Strategy, the MHRA has committed to: Lead real‑world evidence generation and regulation Deliver operational excellence Provide patient-centred regulation Tackle the trade in illegal medicines Support innovation in life sciences Transform regulation with AI and pioneer MedTech methodologies Increase efficiency through international collaboration It plans to support innovation in life sciences by enabling a shift away from the use of animal models towards human-relevant new approach methodologies (NAMs), reducing regulatory barriers for UK start-ups and smaller companies with a targeted voucher scheme, and developing a more flexible and risk‑proportionate regulatory framework for rare disease therapies. Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry (ABPI), commented: “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. This strategy matches that ambition and, in many areas, goes further. The MHRA’s new strategy is clear on speed, clear on standards and clear on how performance will be measured, with firm service guarantees, closer working with NICE and patients at the centre of every decision. The agency has already made real progress on these issues, and this strategy builds on that progress with confidence.”