REGULATORY FRAME WORK IN DRUG SAFETY AND PHARMACOVIGILANCE

Abstract

Pharmacovigilance is a fundamental component of modern healthcare systems dedicated to thedetection, assessment, monitoring, and prevention of adverse drug reactions (ADRs) and other drug-related problems. With the increasing complexity of therapeutics, biologics, vaccines, and personalized medicine, robust pharmacovigilance systems are essential to ensure patient safety throughout the lifecycle of medicinal products. The evolution of pharmacovigilance was significantly influenced by historical drug-related tragedies, leading to the establishment of global regulatory frameworks. Today, pharmacovigilance integrates spontaneous reporting systems, post-marketing surveillance, electronic health records, real-world evidence, artificial intelligence, and signal detection methodologies. Despite substantial progress, challenges such as underreporting, regulatory inconsistencies, and limited awareness persist, particularly in developing countries. Future perspectives emphasize proactive risk management, precision medicine, global collaboration, and digital transformation. This review discusses the history, importance, regulatory framework, methodologies, challenges, and future directions of pharmacovigilance in ensuring drug safety worldwide.