MRC Centres of Excellence for Regulatory Science and Innovation

Funding to establish a Centre of Excellence for Regulatory Science and Innovation to address strategic regulatory science priorities through sustained programmes of research.

The Medical Research Council (MRC) is offering this opportunity in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Office for Life Sciences (OLS) to establish four Centres of Excellence for Regulatory Science and Innovation (CERSIs) across the UK.

CERSIs will play a vital role in the UK regulatory innovation ecosystem by advancing regulatory science. The programme will support research that develops regulatory science capability and enables translation into regulatory practice. This will help address regulatory challenges and uncertainties, enabling innovative healthcare products and solutions to reach patients safely and more efficiently. The research programmes delivered through CERSIs should address clear regulatory challenges, evidence gaps or emerging issues, with a credible pathway to informing regulatory policy, practice, tools and decision making.

Each CERSI will seek to address regulatory science areas of strategic importance to the UK, by bringing together expertise from: academia, regulators, industry, healthcare providers, patients and public partners, and devolved administrations and local regions. Proposed centres should complement existing investments and infrastructure, connecting relevant expertise and capabilities from devolved administrations and local regions, creating added value that could not be achieved through a collection of separate research projects.

Applications must align with one of the four strategic themes of the CERSI initiative:

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

The funders expect to fund only one CERSI for each of the four CERSI strategic themes. Applications should clearly articulate the primary regulatory science challenge being addressed and explain how the proposed programme complements, rather than duplicates, activity that may be undertaken within other thematic areas. Potential duplication of research activity will be avoided through the proposed governance structures for CERSI oversight.

Unless otherwise stated, themes will encompass:

• Medicines.
• Medical devices including software.
• In vitro diagnostic medical devices.
• Combination products.
• Other healthcare products where relevant.

Patient benefit, patient experience and public confidence are central considerations across all CERSI themes. Applicants should consider how the public will contribute to the proposed research and how the research contributes to patient centred regulation, equitable patient access, and public trust in regulatory process and decision making. Meaningful public partnerships should be embedded throughout the research lifecycle where possible, including in the identification, design, conduct, dissemination and translation of research.