What is MedDRA?
The Medical Dictionary for Regulatory Activities (MedDRA) has been developed as a pragmatic, clinically validated medical terminology with an emphasis on ease-of-use data entry, retrieval, analysis, and display, with a suitable balance between sensitivity and specificity, within the regulatory environment. MedDRA is applicable to all phases of drug development and the health effects of devices. By providing one source of medical terminology, MedDRA improves the effectiveness and transparency of medical product regulation worldwide.