Our aim is to lead to a situation where only effective and safe drugs are available in the pharmaceutical market. Thus, we make best efforts to detect novel, potential threats, and reduce the risk associated with the use of the drug. We evaluate the value of the drug on a regular basis as our scientific knowledge about it accumulates. The risk analysis, i.e., the ratio of the benefits of using the drug to foreseeable risks, is being performed along with the availability of a given medicinal product on the market.
The data analysis is mainly conducted by regulatory agencies in relation to the products registered in a given country and pharma companies – in relation to their products. The data evaluation is also carried out at the international level. The Pharmacovigilance Risk Assessment Committee (PRAC) is a part of the European Medicines Agency (EMA) which operates within the European Union. The PRAC is responsible for assessing all aspects of risk management of human medicines.
The assessment of the drug safety profile involves not only the analysis of individual cases of adverse reactions to medicinal products but also the analysis of aggregate reports prepared by pharma companies. In accordance with the applicable provisions, responsible entities are required to prepare periodic safety reports and appropriate risk management plans (for selected medicinal products).