MHRA and Genomics England to launch pioneering resource to better understand how genetic makeup influences the safety of medicines

A brand-new genetic research resource, known as a ‘biobank’, will be piloted by the Medicines and Healthcare products Regulatory Agency (MHRA) in a joint venture with Genomics England to better understand how a patient’s genetic makeup can impact the safety of their medicines.

The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices. It forms part of a long-term vision for more personalised medicine approaches, as scientists will use the repository of genetic information in the biobank to determine whether a side effect from a medicine was caused by a specific genetic trait. This will in turn enable doctors to target prescriptions using rapid screening tests, so patients across the UK will receive the safest medication for them, based on their genetic makeup.

Adverse Drug Reactions (ADRs), or side effects, continue to be a significant burden on the NHS and account for one in 16 hospital admissions. Understanding the underlying mechanism of an adverse reaction would support the development of pharmacogenetic testing strategies, such as the screening tests enabled through the information provided by the Yellow Card biobank. These strategies would in turn provide the opportunity to prevent rather than react to adverse drug reactions.

The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September.

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Source: MHRA, 25 May 2023