Reporting of ADRs Across the Globe: India, USA, EU, and Non-EU

This chapter conducts a comparative analysis of adverse drug reaction (ADR) reporting practices in four prominent global regions: India, the United States (US), the European Union (EU), and the non-European Union (non-EU). ADR reporting is critical for identifying and addressing unintended harmful effects of medications, contributing to patient safety and healthcare quality. In India, the Pharmacovigilance Program of India (PvPI) oversees reporting through VigiFlow. The Food and Drug Administration (FDA) manages the Adverse Event Reporting System (FAERS) in the US. The European Medicines Agency (EMA) coordinates reporting through EudraVigilance in the EU. Challenges common to all regions include underreporting, data quality, and language diversity. Technological advancements such as digital platforms, automated analysis, artificial intelligence (AI) integration, and mobile apps improve ADR reporting efficiency. Collaboration and data sharing among regions facilitate proactive pharmacovigilance. Recommendations for enhancing ADR reporting encompass awareness campaigns, standardized criteria, patient involvement, AI integration, and international cooperation. Incorporating these recommendations and fostering collaborative learning within the global pharmacovigilance community has the potential to enhance patient safety significantly.