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MedDRA

Medical Dictionary for Regulatory Activities

International terminology for pharmaceutical regulatory communication. Adverse event reporting and drug safety.

regulatoryadverse-eventsdrug-safety
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Class Hierarchy

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Use Cases

When and where you'd use this ontology in practice.

01

Adverse event reporting to FDA/EMA

02

Drug safety signal detection

03

Clinical trial adverse event coding

04

Pharmacovigilance data analysis

Details

Maintained By
ICH
License
Restricted
MedDRA subscription licence (UMLS SRL 3)MedDRA-Subscription

UMLS Source Restriction Level 3 forbids incorporation in any publicly accessible computer-based information system, including the Internet. Publishing MedDRA structure on a public site is not permitted.

Verified against the licence text on 2026-08-07.

Category
Healthcare

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