Risk communication is a two-way exchange of information on the risks and benefits of a medicine. Patients, companies, and health authorities all have important roles to play in risk communication and management.
Benefit and Risk Assessment
Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one of two paths – the decentralised procedure, or the centralised procedure. In some cases in Europe, the centralised procedure is mandatory.
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.
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.
The value of clincal trial results is assessed in light of its design, its participants, the observed effects, and previous medical knowledge.
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.
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory authorities. The regulatory authorities then decide whether or not a medicine can be prescribed to patients.
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.