New centre of excellence for regulation to accelerate digital adoption to ensure faster and safer delivery of medicines to patients

A new £1m research project to realise the transformative potential of digital technologies like artificial intelligence (AI) in medicines development and manufacturing has been announced.

Funded by Innovate UK, the UK’s innovation agency, the 12-month Centre of Excellence in Regulatory Science and Innovation (CERSI) project has ambitions to advance regulatory processes by integrating cutting-edge digital technologies.

The CERSI will support the implementation of Quality by Digital Design (QbDD) across the sector, ensuring confidence in data and digital tools. In doing so, it lays the foundation for future medicines that are affordable, safe, effective, and sustainable.

By fostering collaboration, the CERSI aims to drive regulatory consensus and advance the maturity of digital tools, demonstrated through impactful real-world use cases. Additionally, the CERSI will offer tailored training to build both the technical expertise, and the cultural mindset required to adopt and implement digital approaches successfully.

As one of the most heavily regulated sectors globally, the pharmaceutical industry relies on compliance to ensure safety and maintain public trust. This project unites expertise from across the globe to position the UK at the forefront of modern medicines regulation, paving the way for faster digitally enabled regulatory submissions of life-saving medicines.

The project is led by CMAC (a medicines manufacturing research centre at the University of Strathclyde) and delivered in collaboration with a consortium of partners including an academic institution (De Montfort University), a research organisation (The Cambridge Crystallographic Data Centre, The CCDC), global pharmaceutical companies including (AstraZeneca UK Ltd., Bristol-Myers Squibb, Pfizer) and a leading digital technology company (Siemens).

Daniel Markl, CERSI Project Lead and CMAC Associate Director, said:

“This award highlights the critical role of science and innovation in transforming regulatory processes for medicines. The CERSI will deliver the 21st-century regulatory science and innovation needed to unlock the benefits of new digital technologies for industry, regulators and society. This is vital to ensure the safety of new medicines while accelerating the delivery of safe, innovative, and environmentally sustainable therapies to patients.

The CERSI represents a major step forward in developing a framework that ensures the accuracy, robustness, quality, and suitability of digital tools, enabling their confident adoption by industry and regulators. By driving UK and international regulatory policy and practice, we are committed to delivering the science and innovation needed to position regulation as a growth enabler, embracing new approaches and regulatory models to benefit patients worldwide.”

Science Minister, Lord Vallance, said in his announcement to UKRI:

“New technologies are transforming our economy at a rapid pace. Our system of regulation must keep up with that so that we can quickly and safely seize the economic and social benefits that new innovations could unlock. This is particularly true for life sciences, where innovative medical technologies, treatments, diagnoses and therapies are just around the corner.

“That is why we are launching CERSIs. They will make a valuable contribution to regulatory innovation – and will complement wider efforts to make the UK’s regulation fit for the future, such as that of our Regulatory Innovation Office.”