Role of Real-World Evidence in Pharmacovigilance: From Signal Detection to Regulatory Decision-Making – A Narrative review

Abstract

Pharmacovigilance plays an important role in ensuring the safety of medicines after they are introduced
into clinical practice. Although randomized controlled trials are essential for evaluating the safety and
efficacy of drugs before approval, they often fail to identify rare or delayed adverse drug reactions
because they involve limited patient populations and are conducted under controlled conditions. Real-
world evidence (RWE), generated from sources such as electronic health records, patient registries,
insurance claims databases, spontaneous adverse drug reaction reporting systems, and digital health
technologies, provides valuable information on the safety and effectiveness of medicines in routine
clinical settings. In recent years, RWE has become an important component of pharmacovigilance by
supporting early safety signal detection, risk assessment, regulatory decision-making, and continuous
evaluation of marketed medicines. This review discusses the role of real-world evidence in
pharmacovigilance, the major sources of real-world data, important drug withdrawal case studies,
current challenges, and future developments, including the application of artificial intelligence and big
data in drug safety monitoring