Meddra Coding in Pharmacovigilance: A comprehensive review of Its role, challenges, and best practices in adverse event reporting and regulatory compliance

Abstract

MedDRA (Medical Dictionary for Regulatory Activities) plays a pivotal role in pharmacovigilance, enabling standardized coding of adverse events, clinical conditions, and medical interventions. This standardized terminology allows for consistent and accurate communication between pharmaceutical companies, healthcare professionals, and regulatory authorities worldwide. Its hierarchical structure, composed of five levels ranging from System Organ Class (SOC) to Lowest Level Term (LLT), provides a comprehensive framework for describing medical events. Accurate MedDRA coding is essential for the detection of safety signals and plays a crucial role in post-marketing surveillance, clinical trial reporting, and risk assessment. This review explores the significance of MedDRA coding within pharmacovigilance systems, highlighting its impact on adverse event reporting, regulatory compliance, and overall drug safety. We discuss the challenges associated with MedDRA coding, including its complexity and the need for continual updates. Additionally, we delve into best practices for implementing MedDRA coding, such as maintaining quality control mechanisms and providing thorough training for pharmacovigilance professionals. The review also addresses the use of automated tools for coding and their potential advantages and limitations. By offering an in-depth understanding of MedDRA’s application in pharmacovigilance, this review aims to contribute to the improvement of drug safety reporting and enhance regulatory communication worldwide.