Pharmacovigilance (PV) is the science and regulatory activity devoted to the detection, assessment, understanding, and prevention of adverse effects of medicines. For pharmaceutical industries, PV constitutes both a statutory obligation and a fundamental public health commitment, operating across the entire product lifecycle from pre-clinical development through post-market surveillance. This concise review examines the historical evolution of pharmacovigilance, its global regulatory architecture, core industry activities including adverse drug reaction (ADR) reporting, signal detection, periodic safety reporting, and risk management planning, as well as the transformative impact of artificial intelligence (AI), real-world data (RWD), and patient-centric approaches on contemporary PV practice. Three structured tables and an ADR classification framework are presented to consolidate essential knowledge. Challenges including underreporting, global harmonization gaps, and digital regulatory adaptation are discussed alongside future perspectives. Thirty peer-reviewed references and authoritative regulatory guidelines underpin the analysis.
Yadav et al. (Thu,) studied this question.