Year: 2025
Type: article
Abstract: Pharmacovigilance (PV) plays a critical role in ensuring drug safety by monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) and other medication-related risks. This review explores the evolution of pharmacovigilance, from its historical foundations to modern advancements in artificial intelligence, big data analytics, and real-world evidence (RWE). Key topics include global regulatory frameworks (e.g., WHO, ICH, FDA, EMA), methodologies for signal detection, risk management plans (RMPs), and the growing importance of patient-reported outcomes. Challenges such as underreporting, data quality, and globalization of drug markets are discussed, alongside emerging trends like digital pharmacovigilance and vaccine safety surveillance. The article underscores the need for robust PV systems to enhance public health and foster trust in therapeutic interventions.
Author: Mr. Narendra Kaluram Choudhari
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W4409764734