UK MHRA Says Genetic Biobank Could Transform Drug Safety Monitoring

The biobank, which the UK regulator believes puts it at the forefront of innovation in the field of drug safety monitoring, will enter a pilot in June, starting with the gout treatment allopurinol and related rare, severe skin reactions.

Gene therapy
The Yellow Card biobank will contain genetic data and patient samples • Source: Shutterstock

The UK regulatory agency, the MHRA, says it is set to become the first regulator worldwide to pilot its own genetic “biobank,” in an initiative that it believes could transform its safety monitoring activities by enabling a better understanding of how a patient’s genetic makeup can impact the safety of the medicines they take.

The Yellow Card biobank, to be launched on 1 June, will contain genetic data and patient samples, and will operate alongside the agency’s Yellow Card reporting site for suspected side...

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