Off-label use of a medicine is the use of an authorised medicine by a healthcare professional to treat a patient in a way not covered by the Marketing Authorisation (MA) and detailed in the Summary of Product Characteristics (SmPC) of the medicine.
Pharmacovigilance is the practice of detecting, understanding, and preventing adverse events or any other medicine-related problem.
EudraVigilance is an EU web-based information system, designed to manage safety report data created by the European Medicines Agency (EMA) containing adverse reaction reports (ADRs) for medicines authorised in the EU.
Risk management is important in medicines development and pharmacovigilance in order to avoid crisis situations and harmful consequences. There are various kinds of risk; risk management strategies must assess and minimise these, and balance them with the benefits of the medicine being developed.
Life-cycle management activities begin as soon as a medicine receives authorisation from the regulatory authorities. Research on the medicine continues in order to gather additional data on safety and investigate other possible indications that the medicine might treat.
Medicines must balance efficacy and safety, benefits and risks. The efficacy and safety of a medicinal product are tested thoroughly during its development, and carefully monitored after the product enters the market.