Each new Centre of Excellence for Regulatory Science and Innovation will be funded for up to five years. 

The new programme has been developed through a partnership between the Medicines and Healthcare products Regulatory Agency (MHRA), the Medical Research Council (MRC), and the Office for Life Sciences (OLS). 

The four Centres of Excellence for Regulatory Science and Innovation (CERSIs) will bring together world-leading expertise from across academia, industry and healthcare and develop practical solutions to emerging regulatory challenges. They will also help to ensure new innovations can be safely adopted in practice.

Previously, a CERSI pilot established seven centres working across areas including AI, digital health, in-vitro diagnostics, advanced therapies, chemistry, manufacturing and controls, and pharmacogenomics. The new partnership programme will build on the pilot and focus on strengthening UK capability in regulatory science and addressing emerging challenges across health and life sciences.

Co-funding of the four new CERSIs is shared between the MRC and OLS, and the programme combines the MRC’s expertise in funding and supporting world-leading research with the MHRA’s regulatory science expertise. 

Following extensive engagement across the sector, the programme has identified four strategic areas where regulatory science capability is required to support the next generation of healthcare innovation. These are: data-driven approaches and artificial intelligence; prevention, early detection and novel evidence approaches; personalised healthcare and pharmacogenomics, and novel platform technologies.

Addressing emerging regulatory challenges

“The biggest challenges facing healthcare innovations can’t be solved by any one organisation alone,” said Jacob George, professor of cardiovascular medicine and chief medical and scientific officer at the MHRA. “These CERSIs will bring together the right expertise from across the system to help us address emerging challenges in regulation, keep pace with advances in science and technology, and ultimately help patients benefit from new innovations more quickly and safely.”

George added that the programme also supports the UK’s wider life sciences ambitions by helping to strengthen the expertise and partnerships needed to maintain the UK’s position as a leading destination for scientific research, innovation and investment.

“Advances in areas such as artificial intelligence, personalised healthcare and novel technologies are creating exciting opportunities to improve people’s lives,” added Patrick Chinnery, professor of neurology and the MRC’s executive chair.

“Through this partnership with the MHRA and OLS, we are inviting applications that bring together researchers, regulators and innovators to help ensure regulation keeps pace with innovation to deliver for patients, strengthen the health system and support the UK’s world-leading life sciences sector.”