Review on Pharmacovigilance

Pharmacovigilance involves the science and practice of identifying, evaluating, understanding, and preventing adverse effects or other issues related to drugs. The legal framework governing pharmacovigilance for medicinal products in the EU/European Economic Area (EEA) is outlined in a series of Directives that detail the responsibilities of marketing authorization holders and regulatory agencies. Experiences from the past two decades with medicines have highlighted the crucial need for a systematic approach to studying drug safety and managing drug risks. Among all the fields discussed in this chapter, pharmacovigilance has particularly advanced within the pharmaceutical industry and its regulatory bodies.