Pharmacovigilance
Pharmacovigilance is the science and activities concerned with the detection, assessment, comprehension, and prevention of adverse effects or other medical problems. The European Medicines Agency (EMA) coordinates the pharmacovigilance system in the European Union (EU) and operates services and processes to support pharmacovigilance in the EU.
Before a medicine is approved for use, evidence of its safety and efficacy is limited to clinical trial results, in which patients are carefully selected and closely monitored under controlled conditions. This means that at the time of approval, a medicine had been tested in a relatively small number of carefully selected patients for a limited period of time