Authors: Dr. Anjali Mehta, Mr. Vikram Singh
ABSTRACT: Adverse Drug Reaction (ADR) reporting systems form the backbone of pharmacovigilance, ensuring early detection of drug-related safety concerns. This paper explores the structure, methodologies, and effectiveness of various ADR reporting systems, with emphasis on spontaneous reporting, electronic reporting platforms, and integrated real-world data sources. Comparative analysis of international frameworks including the European Medicines Agency (EMA), US Food and Drug Administration (FDA), and India’s Pharmacovigilance Programme (PvPI) is provided. The paper discusses challenges such as underreporting, data quality issues, and the integration of artificial intelligence for signal detection. Tables summarizing reporting methods, regulatory requirements, and technological innovations provide practical insights for stakeholders. Emphasis is placed on harmonizing global practices, enhancing reporting culture, and employing technological tools to strengthen patient safety and pharmacovigilance efficiency.
KEYWORDS: Adverse Drug Reaction, ADR Reporting Systems, Pharmacovigilance, EMA, FDA, PvPI, Signal Detection, Patient Safety
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