Medical Dictionary for Regulatory Activities (MedDRA) is a standardized medical terminology used to code adverse events, medical history, indications, and other clinical data.
MedDRA coding enables consistent aggregation and analysis of safety data across sites, studies, and sponsors. It supports regulatory submissions and pharmacovigilance by improving comparability and reducing ambiguity in event descriptions. Accurate MedDRA coding is essential for signal detection, safety trend evaluation, and consistent reporting to regulators. Use of MedDRA strengthens data quality and interoperability across global development programs.