Authors: Dr. Meera Iyer, Mr. Rahul Deshmukh
ABSTRACT: Good Pharmacovigilance Practices (GVP) constitute a standardized framework aimed at ensuring drug safety through systematic collection, analysis, and reporting of adverse drug reactions (ADRs). This paper provides a comprehensive overview of GVP guidelines, comparing global regulatory perspectives including the European Medicines Agency (EMA), US Food and Drug Administration (FDA), and India’s Central Drugs Standard Control Organization (CDSCO). Key components such as signal detection, risk management, periodic safety reports, and compliance monitoring are discussed in detail. The paper highlights the challenges faced in implementing GVP across different healthcare systems and emphasizes best practices for harmonization. Tables summarizing core principles and regulatory requirements provide practical insights for healthcare professionals and pharmaceutical companies. Emphasis is placed on the adoption of technology and international collaboration to enhance pharmacovigilance efficiency and ensure patient safety.
KEYWORDS: Good Pharmacovigilance Practices, ADR Reporting, Signal Detection, Risk Management, EMA, FDA, CDSCO
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