Centres of Excellence for Regulatory Science and Innovation (Grant)

Apply for funding to establish a Centre of Excellence for Regulatory Science and Innovation (CERSI) to address strategic regulatory science priorities through sustained programmes of research. You must be based at a UK research organisation eligible for Medical Research Council (MRC) funding. CERSIs will be funded for up to five years, your award will initially last for three years, with a further two years dependent on government spending review and budget allocation. We expect to fund four CERSIs. Demand management Demand management is not being applied to this funding opportunity. Aim Through this funding opportunity, the MRC, Medicines and Healthcare products Regulatory Agency (MHRA) and the Office for Life Sciences (OLS), aim to establish four Centres of Excellence for Regulatory Science and Innovation (CERSIs) across the UK. 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 • devolved administrations and local regions CERSIs will play a vital role in the UK regulatory innovation ecosystem by advancing regulatory science. This will help address regulatory challenges and uncertainties, enabling innovative healthcare products and solutions to reach patients safely and more efficiently. CERSI aims CERSIs will support the development of the evidence, methods and tools needed for future regulatory decision-making, while supporting their translation into regulatory practice. CERSIs will strengthen the UK’s position as a global leader in regulatory science and support safe, effective and timely patient access to healthcare innovation. 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 • decision making Creating national capability The intention is to fund four centres that deliver research excellence while creating national capability in priority areas of regulatory science. 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. The CERSI initiative aims to generate broadly applicable regulatory science: • knowledge • methods • tools • standards Research solely focused on an individual healthcare product without broad applicability is not in scope. Adaptive portfolio to respond to emerging priorities Regulatory science priorities are expected to evolve over the lifetime of the award. CERSI research programmes will therefore operate as an adaptive portfolio, informed by: • horizon scanning • engagement with regulators • researchers • patients • industry and other stakeholders • devolved administrations and local regions • oversight of the wider CERSI programme Centres will be expected to respond to emerging regulatory science priorities in areas related to their CERSI theme, identified through CERSI governance arrangements. Where required, centres will adapt elements of their work programmes to address these priorities, while continuing to deliver their core objectives and maintaining scientific excellence. UK CERSI model UK CERSIs were initially established in 2025 by MHRA, OLS, Innovate UK and MRC following a recommendation in Professor McLean’s 2023 Pro-innovation Regulation of Technologies Review. CERSIs support the Life Sciences Sector Plan ambition for the UK to be a global leader in regulation by 2035. Seven pilot centres received one year of seed funding to test and develop new approaches to regulatory science research and collaboration across different themes. Lessons learned have informed the design of an enhanced UK CERSI initiative. A key change is the provision of programme funding for up to five years, recognising that addressing complex regulatory science challenges requires sustained investment in: • knowledge • expertise • capability • partnerships This longer-term funding model will support CERSIs to build enduring partnerships between the research community, regulators and wider stakeholders. This will provide a mechanism to identify, investigate and translate solutions to regulatory science challenges, that cannot be addressed through individual projects alone. CERSIs are part of a wider MHRA framework for de-risking innovation. Emerging technologies are identified through horizon scanning and regulatory intelligence activities. CERSIs then carry out research to address the regulatory challenges these technologies may present. This research may generate: • evidence • methods • tools • standards These outputs may then be used to inform or support activities such as regulatory sandboxes, guidance development, standards and regulatory pathways helping innovations r

This opportunity is open to organisations based in the UK with standard eligibility. Check if your organisation is eligible This funding opportunity is open to all eligible applicants and is not restricted to organisations or individuals that have previously received funding for a CERSI. Who is eligible to apply The nominated centre director (project lead) should lead the application, alongside a leadership team, and with the full support of their host research organisations. To be eligible to apply for this funding opportunity you must: • be from a single eligible research organisation or a partnership of eligible organisations • have the relevant expertise and experience to lead or contribute to a CERSI and its research culture • show how you will strategically direct the CERSI and be actively engaged in the work • focus your application on one of the four CERSI strategic themes For applicants who do not have a contract of employment for the duration of the proposed project, by submitting an application, the research organisation is confirming if it is successful: • contracts will be extended beyond the end date of the project • all necessary support for the project and the applicants will be provided, including mentorship and career development for early career researchers Who is not eligible to apply You are not eligible to apply for this funding opportunity as a project lead if you are based at an international research organisation. This also includes project leads from MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine (LSHTM) or MRC/UVRI (Uganda Virus Research Institute) and LSHTM Uganda Research Unit. If you are employed by any of the following organisations you cannot apply as project lead or project co-lead, but can participate as project partners on an application led by an eligible UK organisation: • businesses • charity and third sector organisations However, charities and third sector organisations that are approved UK Research and Innovation (UKRI) independent research organisations are eligible to apply as project lead or project co-lead. International researchers As MRC is a lead funder for this funding opportunity, international researchers can apply as ‘project co-lead (international)’. Project co-leads (international) make a major intellectual contribution to the design or conduct of the project. Their contribution and added value to the research should be clearly explained and justified in the application, see ‘Applicant and team capability to deliver’. Read the UKRI project co-lead (international) eligibility for more details. Please contact us if you are uncertain about eligibility. Find contacts in the ‘Contact details’ section You should include all other international collaborators (or UK partners not based at approved organisations) as project partners. Equality, diversity and inclusion We are committed to achieving equality of opportunity for all funding applicants. We encourage applications from a diverse range of researchers. We support people to work in a way that suits their personal circumstances. This includes: • career breaks • support for people with caring responsibilities • flexible working • alternative working patterns UKRI can offer disability and accessibility support for UKRI applicants and grant holders during the application and assessment process.

Click here to start an application on the UKRI Funding Service: https://funding-service.ukri.org/OPP1354/apply/1379 We are running this funding opportunity on the new UK Research and Innovation (UKRI) Funding Service so please ensure that your organisation is registered. You cannot apply on the Joint Electronic Submissions (Je-S) system. The project lead is responsible for completing the application process on the Funding Service, but we expect all team members and project partners to contribute to the application. Only the lead research organisation can submit an application to UKRI. To apply Select ‘Start application’ near the beginning of this Funding finder page. • Confirm you are the project lead. • Sign in or create a Funding Service account. To create an account, select your organisation, verify your email address, and set a password. • Answer questions directly in the text boxes. You can save your answers and come back to complete them or work offline and return to copy and paste your answers. If we need you to upload a document, follow the upload instructions in the Funding Service. All questions and assessment criteria are listed in the How to apply section on this Funding finder page. • Allow enough time to check your application in ‘read-only’ view before sending to your research office. • Send the completed application to your research office for checking. They will return it to you if it needs editing. • Your research office will submit the completed and checked application to UKRI. Please be aware that research office and finance teams undertake checks on hosting arrangements and financial eligibility. The ultimate responsibility for ensuring compliance with all opportunity requirements lies with the applicant. Where indicated, you can also demonstrate elements of your responses in visual form if relevant. When including images, you must: • provide a descriptive caption or legend for each image immediately underneath it in the text box (this must be outside the image and counts towards your word limit) • insert each new image on a new line • use files smaller than 5MB and in JPEG, JPG, JPE, JFI, JIF, JFIF, PNG, GIF, BMP or WEBP format Images should only be used to convey important visual information that cannot easily be put into words. The following are not permitted, and your application will be rejected if you include: • sentences or paragraphs of text • tables • excessive quantities of images A few words are permitted where the image would lack clarity without the contextual words, such as a diagram, where text labels are required for an axis or graph column. For more guidance on the Funding Service, see: • how applicants use the Funding Service • how research offices use the Funding Service • how reviewers use the Funding Service References References should be included within the word count of the appropriate question section. You should use your discretion when including references and prioritise those most pertinent to the