Question to the Department of Health and Social Care:

To ask His Majesty's Government what metrics the Medicines and Healthcare products and Regulatory Agency use to monitor and improve their management of the safety of (1) medicine products, (2) medical devices, (3) blood and blood products; and how regularly are these metrics reviewed.

Patient safety is the highest priority for the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA uses a range of metrics to monitor and improve its management of safety.

Specific safety metrics include the total number of safety signals identified for further assessment, the percentage of adverse drug reaction reports processed within agreed timescales, the percentage of potential signals evaluated within five working days, the number of defective medicinal product recalls, and the number of interventions conducted by the Criminal Enforcement Unit that are assessed to have disrupted or degraded an identified criminal threat. Performance against these metrics is outlined in the MHRA’s Annual Report and Accounts. Further metrics are used internally within the MHRA to monitor performance for all types of medicinal products, including medical devices.

For blood components, the MHRA works with the Serious Hazards of Transfusion Steering Group, to measure safety outcomes associated with transfusion and make recommendations to the system to reduce safety incidents through an annual report.

In 2024, the MHRA updated their reporting processes and established a new set of eight key performance indicators. These were outlined in its 2024/25 Business Plan.