MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner
Source: gov.uk (2025-04-01)

Seven new CERSIs came together to showcase how partnerships will modernise regulation in AI, clinical trials, and advanced therapies, bringing innovations to patients sooner.

Last week, the Medicines and Healthcare products Regulatory Agency (MHRA) hosted an event for the seven newly established Centres of Excellence for Regulatory Science and Innovation (CERSIs) to showcase how their projects will help drive advancements in healthcare.

The event held in Westminster, London, brought together for the first time the MHRA and its fellow funding partners – Innovate UK, the Office for Life Sciences, and the Medical Research Council (MRC) – MHRA project sponsors, and key representatives from government, industry and academia to hear directly from the CERSI leads about how their projects had developed since launch at the beginning of the year (https://www.ukri.org/news/developing-regulatory-science-to-advance-healthcare/).

Discussions centred on:
- AI and MedTech – Making sure AI-powered tools are safely developed and integrated into patient care and the wider healthcare system.
- In silico trials – Exploring new approaches to streamline development while maintaining safety.
- Pharmacogenomics and diagnostics – Shifting healthcare from sickness to prevention.
- Cell and gene therapies – Developing laboratory approaches to shared challenges in advanced therapies.
- Modernising manufacture – Using new digital tools to the full in the production of medicines and medical devices.
The session also provided the opportunity to focus on cross-cutting issues, covering:
- Data sharing – A fundamental enabler for all CERSI projects, ensuring responsible and effective use of health data.
- Skills and expertise – Training regulatory scientists to keep pace with rapid medical advancements.
- Patient and public involvement – Embedding patient perspectives in innovation to understand and shape how it impacts their experience of healthcare.
The collective impact of the CERSI initiative will help to ensure patients benefit from innovation and new treatments sooner.

Science and Innovation Minister Lord Vallance and MHRA Chief Executive Dame June Raine led keynote speeches, highlighting the programme’s role in shaping the future of regulatory science.

June Raine, MHRA Chief Executive, said:

“At our CERSIs event this week, the depth of expertise was impressive and there was real excitement about the progress being made. The discussions highlighted a strong commitment to improving access to innovation for patients, shared with our partners Innovate UK, Office of Life Sciences and the MRC. Through the CERSIs, we have a major opportunity to drive advances in regulatory science in the UK – now is the time to turn that potential into action.”

Notes to editors
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
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