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Background to the MHRA

The MHRA is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety, by ensuring that medicines, vaccines, and medical devices meet appropriate standards of safety, quality and efficacy.

The MHRA is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety, by ensuring that medicines, vaccines, and medical devices meet appropriate standards of safety, quality and efficacy.

The MHRA, together with independent expert advice from the Commission on Human Medicines (CHM), is responsible for ensuring that the overall balance of benefits, in terms of effectiveness and risks, of a product is positive at the time of approval and remains so thereafter.

This benefit versus risk analysis continues after approval (a process known as pharmacovigilance) as more information about safety becomes available following use in general clinical practice. 

An important way in which the MHRA monitor this risk benefit is through the Yellow Card scheme, which started in 1964. The scheme collects and monitors information on suspected safety concerns or incidents involving medicines, including vaccines, medical devices, and e-cigarettes. The scheme relies on voluntary reporting of suspected safety concerns or incidents by healthcare professionals and members of the public.

The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation. Further information about the Yellow Card scheme, including its contribution to identifying safety issues can be found on the Yellow Card website.