Four new Centres of Excellence for Regulatory Science and Innovation (CERSIs) have been announced in the UK to ensure regulatory science keeps pace with rapid advances in healthcare and life sciences.

The £20m programme, developed via a partnership between the Medicines and Healthcare products Regulatory Agency (MHRA), Medical Research Council (MRC), and the Office for Life Sciences (OLS), is inviting applications to establish the centres. 

The CERSIs will bring together world-leading expertise from across academia, industry, healthcare and regulation to develop practical solutions to emerging regulatory challenges and help ensure new innovations can be safely adopted in practice.  

Four strategic areas have been identified where capability in regulatory science – which creates science-based methods for regulatory decision making to help bridge the gap between research and policy – is required to support the next generation of healthcare innovation:  

1. Data-driven approaches and artificial intelligence.
2. Prevention, early detection and novel evidence approaches.
3. Personalised healthcare and pharmacogenomics.
4. Novel platform technologies.

Gerard Hanratty, Partner and Head of Health and Life sciences at UK and Ireland law firm Browne Jacobson, said: “Regulatory science has for too long been the unglamorous sibling of the wider life sciences investment story but it is, in reality, the foundation on which everything else depends.

“We have consistently argued that adequately funding and empowering the MHRA is not a 'nice to have', but a prerequisite for the UK being taken seriously as a global destination for life sciences and MedTech investment. This programme makes good on that principle by building the evidence base and expertise the MHRA will need to regulate the next generation of healthcare technologies, rather than playing catch-up once those technologies have already arrived in the market elsewhere.

“The four strategic themes identified – AI and data-driven approaches, prevention and novel evidence, personalised healthcare, and novel platform technologies – are the areas where the current regulatory toolkit is often most stretched. We have seen, in the context of the EU AI Act delays, what happens when the regulatory framework can’t keep pace with innovation. Companies face uncertainty, investors hesitate and patients wait longer for transformative technologies to reach them safely. Building capability in these areas now will help the UK to avoid these pitfalls.

“What is particularly encouraging about this model is the emphasis on bringing together academia, industry, healthcare and regulators in a single forum. Regulatory science can’t be developed in isolation. The regulatory sandbox model the MHRA has already piloted in AI medicines development showed the value of companies testing tools alongside regulators in a controlled environment. CERSIs should operate in the same collaborative spirit – creating a genuine evidence base before mandating or restricting specific uses, rather than attempting to second-guess every risk at the front end.

“Alongside this investment, we would urge the government to use the MHRA's forthcoming five-year strategy as an opportunity to embed these centres within a broader, coherent national architecture for health and life sciences. Regulatory agility and post-market surveillance capability, enhanced alignment between the MHRA and the National Institute for Health and Care Excellence, and a clear international strategy on reciprocal recognition and collaboration with the US Food and Drug Administration, European Medicines Agency and other peer regulators are all vital building blocks in broader structural reforms that will translate scientific excellence into faster, safer access to innovation for patients.”