OVERVIEW
An Innovate UK led programme bringing together businesses, academia and other organisations to build UK‑wide capability in regulatory science and innovation. The networks develop practical, science‑based tools that support smarter, more agile regulation of new products, services and treatments.
AT A GLANCE
Discovery Phase
A six‑month Discovery Phase supported 40 consortia with £50,000 each. All 40 progressed to the Implementation Phase competition; 18 were subsequently funded:
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£6.2m for 7 Centres of Excellence for Regulatory Science and Innovation (CERSIs) in health
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£4.7m for 11 Regulatory Science & Innovation Networks (RS&INs) across non‑health sectors
Implementation Phase
Projects started Dec 2024 – Feb 2025, running 12–15 months
Funding Partners
Innovate UK, Medical Research Council (MRC), Medicines and Healthcare products Regulatory Agency (MHRA), Office for Life Sciences (OLS)
TWO STRANDS
Human Health
In partnership with Innovate UK, Office for Life Sciences (OLS) and the Medical Research Council (MRC), the Medicines and Healthcare products Regulatory Agency (MHRA) has invested £6.2 million across seven centres to support pioneering research in regulatory science. Each centre will receive up to £1 million to lead initiatives in their respective focus areas.
The Seven CERSIs
Clinical Evaluation & Assessment for Regulation of Diagnostic Tests (CLEARED/CERSI IVD)
Led by Psephos Limited, to help create safe availability of diagnostic tests for patients.
​Digital Transformation of Medicines Development and Manufacturing CERSI
Led by University of Strathclyde, accelerating the adoption of digital tools in medicines development.
Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI‑AT)
Led by Cell and Gene Therapy Catapult, streamlining regulation of advanced therapy medicinal products.
Regulatory Science Empowering Innovation in Transformative Digital Health and AI (RADIANT) CERSI
Led by Brunel University, to safely maximise the potential of artificial intelligence (AI) powered healthcare solutions.
Centre of Excellence on In‑silico Regulatory Science and Innovation
Led by The University of Manchester, to integrate evidence from computational models into the regulatory process.
​​​CERSI in AI & Digital Health Technologies (CERSI‑AI)
Led by University of Birmingham, to optimise the regulation of AI and digital healthcare technologies to ensure innovations are safe and effective for patients.
CERSI in Pharmacogenomics
Led by University of Liverpool, to develop guidelines for using pharmacogenomics in practice and attract further investment in this area.
Non-human Health
An Innovate UK core‑funded strand supporting 11 RS&INs across renewable energy, circular economy, agri‑robotics, novel foods, bio‑based materials, biofilms, aquaculture, insect bioconversion, life cycle assessment, digital products and regulator‑supporting AI platforms.
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Full list of RS&INs - RESCUE (end‑of‑life wind), RetroNetZero (housing retrofit), Bio‑based & Biodegradable Materials, Biofilm Alliance, Innovative Aquaculture, Agri‑Robotics, Novel Foods, Life Cycle Assessment, IBC‑Net (insect bioconversion), Advanced Regulatory Innovation Ecosystem, Digital Products Regulation.
Purpose and Rationale
Effective regulation enables innovation by providing certainty for innovators and investors and building public trust. Rapid technological change can outpace regulatory frameworks, creating uncertainty and slowing adoption. This programme invests in collaborative networks to develop tools, datasets and approaches that help regulators and policymakers keep pace and support responsible innovation.
Objectives
→ Build collaboration across academia, industry and regulators
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→ Develop tools, frameworks and guidance for regulatory science
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→ Enable safe adoption of emerging technologies, including AI and digital health
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→ Contribute evidence to inform regulatory policy and practice