Information on medicinal products is provided to patients and healthcare providers in different, carefully regulated ways – including package labelling, package leaflets, and the Summary of Product Characteristics.
Safety of Medicines
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.
Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
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.
Phase III clinical studies, or confirmatory studies, are the final confirmation of the safety and efficacy of a medicine before it can be launched on the market. Phase III studies are the largest, most complicated, and most expensive part of the medicines development process, and nearly 50% of medicines that enter this phase will fail.
Phase I clinical studies, or proof of mechanism studies, test the safety of a medicine in humans. Usually, these studies are carried out in healthy human volunteers.
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.