A new £1 million research initiative led by the University of Strathclyde aims to transform medicines regulation by accelerating the adoption of digital technologies, including artificial intelligence (AI), in drug development and manufacturing.
Funded by Innovate UK, the 12-month Centre of Excellence in Regulatory Science and Innovation (CERSI) project will support the implementation of Quality by Digital Design, ensuring confidence in data and digital technologies to enable the delivery of safe, effective and sustainable medicines.
CERSI will foster collaboration between industry, academia, and regulatory bodies to drive consensus on digital regulatory approaches, demonstrate their real-world application and provide tailored training to equip the sector with the technical expertise and cultural mindset required for digital adoption.
Vital role
Professor Daniel Markl, CERSI Project Lead and Associate Director at CMAC, Strathclyde’s medicines manufacturing research centre, said: “This project highlights the vital role of science and innovation in shaping the future of medicines regulation. By embedding 21st-century regulatory science and innovation, we can unlock the full potential of digital technologies to benefit industry, regulators, and society.
“The CERSI will establish a framework that ensures the accuracy, robustness, and quality of digital tools, giving regulators and industry confidence in their adoption. Through UK and international collaboration, we aim to position regulation as an enabler of innovation, delivering safe and sustainable medicines to patients faster.”
The pharmaceutical industry is one of the most heavily regulated sectors worldwide, with compliance essential to ensuring safety and maintaining public trust. By uniting global expertise, the project aims to place the UK at the forefront of modern medicines regulation, enabling faster, digitally driven approvals of life-saving treatments.
The project is being delivered in collaboration with De Montfort University, the Cambridge Crystallographic Data Centre, AstraZeneca UK, Bristol-Myers Squibb, Pfizer and Siemens.
Science Minister, Lord Vallance, said: “New technologies are transforming our economy at a rapid pace. Our regulatory system must evolve to seize the economic and social benefits of innovation quickly and safely.
“That is why we are launching CERSI, which will contribute to regulatory innovation and complement wider efforts to ensure the UK’s regulatory landscape is fit for the future.”