Description:
This report reviews the pharmacovigilance system of the European Union (EU) mapping out its structure and processes with any eye to features that may be of particular interest to decision makers in other regions as they weigh options related to creating a regional pharmacovigilance architecture for themselves. It begins with a review of the European Medicines Agency (EMA), which plays a central role in the EU system, followed by an overview of the EU PV assessment and monitoring process and an example of the system in action regarding COVID-19 vaccines. It concludes with a summary several key insights of particular relevance for decision makers