Authors: Dr. Sneha Kapoor, Mr. Aditya Sharma
ABSTRACT: Pharmacovigilance regulations play a pivotal role in maintaining the safety, efficacy, and quality of pharmaceutical products worldwide. Regulatory authorities such as the United States Food and Drug Administration (US FDA), European Medicines Agency (EMA), and India’s Central Drugs Standard Control Organization (CDSCO) have established comprehensive frameworks to monitor adverse drug reactions (ADRs) and enforce compliance. This paper examines the regulatory guidelines, reporting requirements, and compliance mechanisms of these agencies. Comparative analysis highlights similarities and differences in reporting timelines, risk management strategies, and inspection protocols. The paper also discusses the challenges faced by pharmaceutical companies in meeting diverse regulatory requirements and emphasizes the importance of harmonization and global collaboration. Tables summarizing key regulatory features and reporting structures are included, providing a practical overview of compliance expectations in the US, EU, and India. Enhanced understanding of these frameworks supports better pharmacovigilance practices and ensures patient safety in global healthcare systems.
KEYWORDS: Pharmacovigilance, US FDA, EMA, CDSCO, Regulatory Compliance, Adverse Drug Reactions, Risk Management
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