In its newly published 2030 strategy, the Medicines and Healthcare products Regulatory Agency (MHRA) has vowed to reduce regulatory barriers for UK start-ups and SMEs, develop a modern regulatory framework for AI as a medical device, and move forward with plans for the use of AI in transforming medicines development.
A strategic priority deliverable under the new strategy is a “real-time, world class safety and surveillance system”, which will harness UK data and AI to better understand medicines and medical device safety in real-world use.
Work is ongoing with partners to improve access to linked hospital data and patient genomics for regulatory purposes, according to the MHRA, and analytical capacity will be advanced through recruitment and the use of AI-enabled tools.
The agency vows to do more to create a “world-class innovation ecosystem”, aiming to identify emerging innovations earlier, and support for proposed legislative reforms to develop statutory mechanisms for regulatory sandboxes.
Conditional approval will also be offered for innovative medical technologies that address unmet clinical needs via the Early Access Service for Devices, ahead of full regulatory assessment.
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