Abstract: Pharmacovigilance (PV) plays a critical role in ensuring drug safety and protecting public health worldwide. Over the decades, global PV systems have evolved significantly—from early-stage spontaneous reporting mechanisms to increasingly sophisticated frameworks that integrate electronic health records, real-world data, and advanced analytics. This review provides a comprehensive overview of the historical development of pharmacovigilance systems across key regions, including the European Union, the United States, and low- and middle-income countries, highlighting the diversity in regulatory approaches and infrastructural capacities. Despite notable progress, the field continues to face persistent challenges such as underreporting, data silos, regulatory fragmentation, and the need for harmonized global practices. The emergence of digital health technologies, artificial intelligence, and global data-sharing initiatives offers promising avenues to strengthen pharmacovigilance systems, improve signal detection, and enhance proactive risk management. This review also explores the future landscape of pharmacovigilance, emphasizing the importance of patient engagement, international collaboration, and adaptive regulatory strategies to meet the complex demands of modern drug safety surveillance.
Keywords: Pharmacovigilance, Drug Safety, Adverse Drug Reactions, Regulatory Systems, Spontaneous Reporting, Artificial Intelligence in Pharmacovigilance.