Significance of ICSRs in Pharmacovigilance: The EU Perspective
Developing novel and essential medicinal products has significantly increased the burden of monitoring and tracking the Adverse Drug Reactions (ADRs) and Adverse Events (AEs) of drug products. An Individual Case Study Report (ICSR) is collected at an individual level, which leads to causality assessment or a tilt in the risk-benefit ratio of a medicinal product to be determined distinctly. In the European Union (EU), the enhanced EudraVigilance system was launched in 2017.