MHRA Strategy 2030 highlights in-silico evidence, digital twins and hybrid trials

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has identified in-silico evidence, digital twins and hybrid clinical trials as priorities in its MHRA Strategy 2030, signalling a continued focus on integrating computational science and data-driven approaches into medicines regulation. The agency plans to expand its capability to assess in-silico evidence, publish new guidance on digital twins and develop regulatory frameworks through its in-silico Centres of Excellence for Regulatory Science and Innovation (CERSI) programme.

The strategy also highlights the potential role of digital twins and synthetic data in enabling hybrid clinical trials, alongside improved access to linked health data to support pharmacovigilance, pharmacogenomics and clinical research. These initiatives aim to strengthen real-world evidence generation and support faster, more informed regulatory decision-making throughout the medicines lifecycle.

For pharmaceutical developers and clinical research organisations, the commitments signal growing regulatory attention to computational modelling and alternative approaches to evidence generation. Future guidance and frameworks will be important in clarifying how these methods can be validated and incorporated into regulatory submissions.

The full strategy is available on the UK Government website.