Pharmacovigilance System in EU

The primary goal of the pharmacovigilance system is to assess every element of risk management in reporting an adverse drug reaction via the pharmacovigilance risk assessment committee. The primary goal of a system is to stimulate the availability of medicine, particularly those that address traditionally unmet therapeutic needs, and lessen the incidence of adverse drug reactions to endorse and protect public health. These are accomplished by using a proactive, risk-proportionate, patient-centered approach, involving civil society, and maintaining significant transparency. Preparation and execution of pharmacovigilance actions before medicine is put on the market in the European Union, which encourages the start of an early development process for high innovation outcomes. The European Union (EU) is a multi-level organization. The role of pharmacovigilance and several institutional relationships at the European and national levels represent the system’s condensed visual depiction. This chapter outlines the system workflow, applications, components, significant challenges, and drivers for future change.