There are a few stages in development of global pharmacovigilance system. These stages include evolution from establishment of first regional institutions such as Food and Drug Administration in USA in 1862 to formation of international systems for adverse drug reactions monitoring (i.e. WHO collaborating center in Sweden Uppsala Monitoring Center); from local regulatory acts, such as Adulteration of Food and Drink Act in Great Britain in 1860 to international regulatory standards (Good Pharmacovigilance Practice or GVP). The aim of the study was to review available literature and determine the milestones in formation and further development of global pharmacovigilance, find trends and define perspectives. We have established the basic stages, processes, factors and main geographical centers (United Kingdom, USA, Sweden etc.) associated with development of the pharmacovigilance system. Particularly, we propose the following milestones: firstly, formation of separate regional institutions; secondly, establishment of global organizations for analysis, storage and interchange of drug safety information, and lastly, integration of pharmacovigilance systems of different countries into one common system for several states (such as EMA) and harmonization of pharmaceutical legislation. In addition, we have described the most important institutions playing key roles in ensuring drug safety at a global level (CIOMS, ICH, WHO UMC and others). We have shown events and cases that have significantly affected development of drug safety institutions and legislation, as well as ones that have resulted in development of current methodology used in pharmacovigilance. Particular attention was paid to public non-commercial organizations playing important roles in training drug-safety specialists for regulatory organizations, academic institutions and pharmaceutical companies.

Full version