ROLE OF MedDRA IN PHARMACOVIGILANCE: STANDARDIZED CODING FOR ADVERSE DRUG REACTIONS

Adverse drug reactions (ADRs) are a major concern for patients, physicians and regulatory agencies worldwide. Pharmacovigilance requires a standardized approach for coding and sharing safety data for effective risk monitoring. This international standard is the Medical Dictionary for Regulatory Activities (MedDRA). This review describes the structure, regulatory mandate, signal detection capabilities, and coding challenges of MedDRA within the framework of pharmacovigilance. MedDRA is organized hierarchically in five levels from the most specific Lowest Level Terms (LLTs) to the most general System Organ Classes (SOCs). This is required by major regulators such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The World Health Organization (WHO) also uses it globally to code millions of safety reports. The role of MedDRA during signal detection is important with the help of tools such as Standardized MedDRA Queries (SMQs) which facilitate rapid identification of new side effects. But the system has its own problems. Inconsistent coding, changing terminology and the need for constant training may compromise data quality. Still, MedDRA is an important basis for global safety surveillance. The future is bright for MedDRA with increased use of automation and artificial intelligence to accelerate and improve pharmacovigilance.