The Medicines and Healthcare products Regulatory Agency (MHRA) unveiled its 2030 Strategy to modernise patient-centred regulation amid advances in AI, personalised medicine, and digital healthcare, with a focus on improving patient outcomes and speeding safe treatments to patients.

The strategy expands access to real-world data and genomics programmes, uses AI for safety data analysis and post-market surveillance, and aims to simplify adverse event reporting through the Yellow Card system.

An AI-enabled Clinical Trial Protocol Checker and an AI Medicines Development Action Plan are planned for 2027, alongside an annual regulatory science conference to elevate MHRA’s international standing.

MHRA commits to investing in people, emphasising skills, leadership, and culture to maintain an expert, adaptable, high-performing organisation built on trust and empowerment.

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A core value remains putting patients at the centre, with open, transparent, and inclusive regulatory decisions shaped with patients and the public.

International collaboration is a central pillar, with expanded reliance on trusted regulators, Regulatory Innovation Corridors, leadership of the Access Consortium, and hosting an annual regulatory science conference to reinforce global leadership.

Partnerships with the FDA, European regulators, and global partners aim to streamline submissions, share safety information, and strengthen supply chains while upholding high standards.

Strengthened ties with the FDA, recognition of CE-marked devices, and leadership of the Access Consortium are highlighted, along with plans for regular regulatory science discussions.

Smaller companies will be supported through a targeted voucher scheme and enhanced investment in laboratory capacity, real-world evidence, computational modelling, digital twins, synthetic data, and alternatives to animal testing such as organoids and organ-on-a-chip technologies.

Targets include reducing scientific advice turnaround to 45 days, halving Phase 1 trial initial assessments to 14 days, and delivering quicker decisions for generics and biosimilars to improve patient access and NHS savings.

The strategy introduces a premium scientific advice service and a more flexible framework for rare disease therapies to speed access to innovative treatments.