Harmonized pharmacovigilance practices: a pathway to safer pharmaceuticals in a globalized industry

Pharmacovigilance practices have focused on the reporting of adverse drug reactions to medicinal products. In an increasingly global industry, attempts have been made to harmonize pharmacovigilance practices internationally in order to advance the knowledge of a medicines safety profile and to ensure that new information is both identified as quickly as possible and communicated to all those potentially impacted. While pharmacovigilance has evolved in recent years, there still remain areas of disharmony in international practices. This thesis compared the pharmacovigilance legislation in the United States with that of the European Union in order to establish what areas of current legislation were harmonized between the regions. Comparisons were also made between the health authorities requirements and the recommendations of international organizations. By establishing where disharmony exists, efforts can more efficiently address strategies to create a pharmacovigilance system that can be implemented internationally, thus promoting the safer use of medicines.