Based on the linked source; automatically prepared and checked against the original report.
Faster regulatory pathways
The Medicines and Healthcare products Regulatory Agency says its strategy will modernise regulation as artificial intelligence, genomics, advanced diagnostics and personalised medicine develop. Planned measures include an enhanced scientific advice service, reducing the stated turnaround target from 90 to 45 days, and a 14-day initial assessment target for qualifying Phase 1 trials. The agency also plans faster decisions on generic and biosimilar medicines.
Device recognition and traceability
The MHRA is considering indefinite Great Britain recognition of devices compliant with EU medical-device and in-vitro diagnostic regulations, but has not confirmed that all CE-marked devices would qualify. It also plans to explore cooperation with the US Food and Drug Administration and participation in the Medical Device Single Audit Program. Proposed regulations, subject to Parliament, would require unique device identifiers or an equivalent system for most devices, with stated exceptions.
Data, enforcement and inclusion
The regulator plans wider access to hospital and genomics data, increased use of AI in safety surveillance, and a simpler Yellow Card process for adverse-event reporting. Registration, reporting and public-information systems are due for upgrade or replacement. The strategy also proposes stronger action against illegal medicines and devices, collaboration with online platforms, support for smaller companies, and a new Centre for AI and Digital Health. It includes commitments on clinical-research diversity, a Women’s Health Plan and greater patient involvement.
