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.
The journey of a drug product doesn’t end with its post-market authorization. The drug’s performance is now openly evaluated by the general population. To safeguard the population against any undesirable outcomes, post the consumption of a drug, a pharmacovigilance alert system is in place. A risk management committee of experts monitors drug safety and evaluates every alert signal issued by the people to address the concern.