Medicines and Healthcare products Regulatory Agency (MHRA)
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Who are we?
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK.
We put patients first in everything we do, right across the lifecycle of the products we regulate. We rigorously use science and data to inform our decisions, enable medical innovation and to make sure that medicines and healthcare products available in the UK are safe and effective.
Our responsibilities are to:
- ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy (effectiveness)
- secure safe supply chain for medicines, medical devices and blood components
- promote international standardisation and harmonisation to assure the effectiveness and safety of biological medicines
- educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use
- enable innovation and research and development that is beneficial to public health
- collaborate with partners in the UK and internationally to support our mission to enable the earliest access to safe medicines and medical devices and to protect public health
What is the Yellow Card scheme?
The MHRA runs the Yellow Card scheme, which collects and monitors information on suspected safety concerns involving healthcare products, like a side effect with a medicine or an adverse medical device incident. The scheme relies on voluntary reporting of problems to a healthcare product by the public (including patients, parents and carer givers) as well as from healthcare professionals. The scheme also collects suspected safety concerns involving defective (not of an acceptable quality), falsified or fake healthcare products.
What is Yellow Card Biobank?
The Yellow Card Biobank, is a collaboration between the MHRA and Genomics England, investigating pharmacogenomic links to adverse drug reactions. We are looking for patients that have experienced severe bleeds from direct oral anticoagulants and severe skin reactions from allopurinol to join the study or healthcare professionals that see these patients. Please come to the Yellow Card stand to ask questions you might have, or contact: yellowcardbiobank@mhra.gov.uk
