Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make an (a) economic and (b) regulatory assessment of the potential impact of In Silico computer modelling and simulation methods on the (i) pharmaceutical and (ii) medical device sectors.

Funding has recently been established through the Centre of Excellence in In-Silico Regulatory Science and Innovation (CERSI). This CERSI cements the United Kingdom’s role at the forefront of regulatory science, driving forward the innovations of tomorrow while upholding our unwavering commitment to public health. This first-of-its-kind programme embeds innovation at the very heart of our regulatory processes.

It will make a substantial contribution to the development of a regulatory framework to support the adoption and assessments of these technologies. It will support and safely accelerate clinical investigation and trial regulatory assessments, improve patient safety, and reduce the time to safely allow the devices or medications to be used by the patients who need them. It will reduce the time to develop and take a device or medication to the market, reducing the cost of drug development. Therefore, it will position the UK globally as one of the best places to conduct safe and effective investigations and trials.

These activities will be led by this CERSI in collaboration with the Medicine and Healthcare products Regulatory Agency and Innovate UK.