Volume-2 ,Issue-5, May-2026

Pharmacovigilance is essential for ensuring drug safety by detecting, assessing, and preventing adverse drug reactions (ADRs) throughout the lifecycle of medicinal products. The Medical Dictionary for Regulatory Activities (MedDRA) serves as the global standard medical terminology that enables uniform coding and analysis of adverse event data across clinical trials, spontaneous reporting systems, and post-marketing surveillance databases. Its hierarchical structure, ranging from Lowest Level Terms (LLTs) to System Organ Classes (SOCs), facilitates consistent data standardization and improves the accuracy of signal detection methods such as data mining and disproportionality analysis in global databases like FAERS, EudraVigilance, and VigiBase. MedDRA also plays a key role in risk management processes, including risk management plans, risk minimization strategies, and continuous safety monitoring in clinical practice. Recent advancements in artificial intelligence, natural language processing, and real-world evidence integration are further enhancing MedDRA-based pharmacovigilance systems by enabling faster and more efficient detection of safety signals. Despite challenges such as coding variability, structural complexity, and implementation issues, MedDRA remains a cornerstone of modern pharmacovigilance, significantly contributing to global drug safety assessment and regulatory decision-making.

Keyword: MedDRA, pharmacovigilance, signal detection, risk management, adverse drug reactions (ADRs)