Pharmacovigilance has emerged as a critical pillar of contemporary healthcare systems, transitioning from a passive adverse drug reaction (ADR) reporting mechanism to a proactive, technology-driven discipline. This review systematically evaluates the evolution, current landscape, and future trajectory of pharmacovigilance within the global healthcare ecosystem. The increasing complexity of therapeutic interventions, including biologics, biosimilars, and personalized medicine, necessitates robust safety monitoring frameworks that extend beyond traditional pharmacovigilance methodologies. A structured literature review methodology was employed, analyzing peer-reviewed articles, regulatory reports, and global pharmacovigilance guidelines published between 2000 and 2024. The findings highlight the integration of artificial intelligence (AI), machine learning, and real-world evidence (RWE) as transformative forces enhancing signal detection, risk assessment, and regulatory decision-making. Furthermore, global harmonization efforts led by regulatory authorities such as the World Health Organization (WHO), International Council for Harmonisation (ICH), and regional agencies have significantly improved pharmacovigilance efficiency and transparency. However, persistent challenges remain, including underreporting of ADRs, data heterogeneity, regulatory disparities, and ethical concerns regarding patient data privacy. The COVID-19 pandemic further underscored the necessity for real-time pharmacovigilance systems to monitor vaccine safety and maintain public trust. This review concludes that pharmacovigilance is no longer solely a regulatory obligation but a strategic enabler of healthcare sustainability and pharmaceutical innovation. Future directions emphasize predictive pharmacovigilance models, digital integration, and patient-centric frameworks to ensure improved therapeutic safety outcomes.
Devanssh Mehta* (Sat,) studied this question.