ICH-MEDDRA

ICH pharmacovigilance terminology.

Definition

MedDRA v27.0 (March 2024) holds ~85000 terms structured in 5 levels: SOC (System Organ Class) → HLGT → HLT → PT (Preferred Term) → LLT (Lowest Level Term). MSSO (MedDRA Maintenance Service Organization) handles semi-annual release. Adopted by FDA, EMA, PMDA, NMPA, ANVISA. MSSO licence terms.

Origin

MedDRA v1.0 published 1994 ; ICH/MSSO management since 1999 (Northrop Grumman).

Example in context

A Sanofi pharmacovigilance case reporting moderate nausea is coded MedDRA PT 10028813 and specific LLT ; transmitted as ICSR E2B(R3) to FDA.

Related terms

• eCTD FDA — use in submissions.