Guidance

Centres of Excellence for Regulatory Science and Innovation (CERSIs)

Published 2 December 2025

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CERSIs aim to drive the development of safer and more effective medicines and medical products and ensure timely access for patients.

By establishing a network of centres, launched in early 2025, CERSIs represent a landmark initiative in regulatory science. CERSIs foster collaboration between academia, industry and regulators to accelerate the delivery of safe innovation in human health.

Main focus areas

In operation since early 2025 and set to complete in early 2026, CERSIs cover the following areas:

  • Advanced Therapies: Streamlining regulation for advanced therapy medicinal products (ATMPs) to ensure faster and safer patient access.
  • Digital Health and AI: Maximising the potential of AI-powered healthcare solutions, including diagnostics and digital health technologies.
  • In-silico Methods: Integrating computational models and digital simulations into regulatory decision-making.
  • Diagnostics: Improving clinical validation and regulatory pathways for diagnostic tests to ensure safe availability for patients.
  • Pharmacogenomics: Developing guidelines for pharmacogenomics, supporting the integration of genetic data into personalised medicine and NHS practice.
  • Advanced Manufacturing and Digital Innovation: Driving digital transformation in pharmaceutical manufacturing, integrating AI, automation, and data-driven approaches to enhance efficiency and scalability.

Objectives

  • Promote collaboration between academia, industry, and regulators to address key challenges in regulatory science
  • Develop tools, frameworks and guidance to streamline the development and approval processes for medical innovations
  • Enhance the integration of emerging technologies, such as artificial intelligence and digital health solutions, into regulatory practices

Funding and support

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 funded CERSIs

1. Centre of Excellence in Regulatory Science and Innovation for the Digital Transformation of Medicines Development and Manufacturing (Digital CMC CERSI)

Lead: University of Strathclyde

Objective: Accelerating the adoption of digital tools in medicine development and manufacturing and in regulatory processes to ensure faster, more efficient delivery of medicines to patients with reduced environmental impact.

2. Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT)

Lead: Cell and Gene Therapy Catapult

Objective: Streamlining regulation for Advanced Therapy Medicinal Products (ATMPs), ensuring the UK has a world-leading regulatory environment that best supports ATMP innovation and faster and safer patient access.

3. Regulatory Science Empowering Innovation in Transformative Digital Health and AI (RADIANT CERSI)

Lead: Brunel University of London

Objective: Safely maximising the potential of AI-powered healthcare solutions, including diagnostics and digital health technologies, ensuring that they are safe, effective, and trusted to enable the continued growth of the sector.

4. Centre of Excellence on In-silico Regulatory Science and Innovation (CEiRSI)

Lead: The University of Manchester

Objective: Integrating computational models and digital simulations into regulatory decision-making to revolutionise the medical product development process, pioneering safer, faster and more effective medical products.

5. Clinical Evaluation and Assessment for Regulation of Diagnostic Tests (CERSI IVD)

Lead: Psephos Biomedica

Objective: Improving clinical validation and regulatory pathways for diagnostic tests, driving innovation and ensuring safe availability for patients.

6. Centre of Excellence for Regulatory Science and Innovation in AI and Digital Health (CERSI-AI)

Lead: University of Birmingham

Objective: Helping create the regulatory system of the future, optimised for AI and advanced digital health products to ensure safety and effectiveness, and to enable faster patient access.

7. Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI-PGx)

Lead: University of Liverpool

Objective: Developing guidelines for pharmacogenomics, supporting the integration of genetic data into personalised medicine and NHS practice.

Engagement

CERSIs are actively seeking collaboration with stakeholders across the healthcare ecosystem. Opportunities for engagement may include:

  • Participating in workshops and seminars
  • Collaborating in research projects
  • Contributing to the development of frameworks and guidance

Contact

For further information on any of the specific services, please contact: CERSI@mhra.gov.uk

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