Committee on safety in medicines

The British Government agency that must approve new pharmaceutical products for sale within the United Kingdom. In concert with the Medicines Control Agency (MCA), it regulates all pharmaceutical products in the United Kingdom. It is the equivalent of the U.S. Food and Drug Administration.


The official body which advises the British Government on the safety and quality of medicines.


An independent advisory committee — launched in 1971 in the United Kingdom — composed of doctors, pharmacists and other specialists. It advises the Medicines & Healthcare Regulatory Agency in the UK on the safety, efficacy and pharmaceutical quality of medicines for which licences are sought, and also reviews reports of adverse reactions to licensed medicines, including spontaneous ‘Yellow Card’ reports from doctors or pharmacists who suspect that a patient has suffered an adverse reaction from a medicine.


 


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