UK – MHRA Regulatory Innovation Corridor

As part of this first-of-its-kind partnership between the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Singapore’s Health Sciences Authority (HSA), companies will have a coordinated fast track pathway to engage both regulators at the same time. Under the new corridor, developers will be able to seek joint advice from both regulators early, helping them plan ahead and design better clinical trials, avoid duplication and reduce delays.

The aim is to speed up patient access to breakthrough therapies in high-impact areas such as cancer, dementia, obesity, rare diseases and advanced diagnostics – without compromising on safety – while strengthening both countries’ position as global hubs for life science investment.

The partnership builds on a long track record of UK–Singapore cooperation in science and technology. Together, the MHRA and HSA will work more closely on early diagnosis, prevention, healthy ageing and digital health, and supporting national strategies in both countries – including England’s 10-Year Health Plan and Singapore’s Healthier SG initiative.

The collaboration will be supported by joint work on AI in healthcare, with both regulators acting as the first two pioneer countries in the HealthAI Global Regulatory Network, and also draw on the UK’s National Commission into the Regulation of AI in Healthcare. HSA Chief Executive Adjunct Professor (Dr) Raymond Chua has recently joined the National Commission as a member, bringing Singapore’s regulatory expertise to help develop the new framework for AI in healthcare.

This new route forms part of wider efforts to unlock growth in UK life sciences and make it simpler for global innovators to bring safe, effective medicines and medical technologies to patients. Recent MHRA initiatives include its AI Airlock – a regulatory sandbox for AI medical devices – which lets companies test new tools with the regulator before wider NHS roll-out; the Innovative Licensing and Access Pathway (ILAP) which streamlines development in areas of urgent unmet need; and its Centres of Excellence for Regulatory Science and Innovation (CERSIs) working directly with researchers to navigate complex science. Together, these changes are designed to streamline development, support investment and provide clearer routes for companies working at the cutting edge of science.

It also builds on HSA’s ongoing efforts to strengthen Singapore’s position as a leading biotech hub, accelerate access to innovative health technologies, and set the pace in global regulatory innovation. HSA’s recent initiatives also include ASCENT1 – the Centre for Advancing Regulatory Science Research in Next-Generation Therapeutics – a partnership between HSA and A*STAR (Agency for Science, Technology and Research) that will strengthen Singapore's position as a global thought leader in evaluating and approving novel biotherapeutics and digital technologies; and the review of the AI in Healthcare Guidelines (AIHGle), published by the Ministry of Health, HSA and national healthtech agency Synapxe, which provides practical guidance for the safe and effective use of AI across Singapore’s healthcare ecosystem. These guidelines are periodically updated to keep pace with emerging AI technologies.

Building on the strong collaborative work through the Access Consortium, both HSA and MHRA will co-create transparent, science-based approaches to assess breakthrough technologies. 

Noubar Afeyan, Ph. D., Founder and CEO of Flagship Pioneering, said: