standards > terminology artifact > DOI:10.25504/FAIRsharing.ad3137

ready Medical Dictionary for Regulatory Activities Terminology

Abbreviation: MedDRA

General Information
MedDRA is a multilingual terminology allowing most users to operate in their native languages. The most important reason to “code” data into a standardised terminology is to analyse it. A key benefit of MedDRA is in its support of straightforward as well as sophisticated analyses. MedDRA can be used to analyse individual medical events (e.g., “Influenza”) or issues involving a system, organ or etiology (e.g., infections) using its hierarchical structure. MedDRA can be used for signal detection and monitoring of clinical syndromes whose symptoms encompass numerous systems or organs using its multiaxial hierarchy or through the special feature of Standardised MedDRA Queries. The ability to communicate adverse event data is another strength of MedDRA and has lead to MedDRA being an integral part of the ICH e-submission standards: eCTD (ICH M8) and ICSRs (ICH E2B).

How to cite this record MedDRA; Medical Dictionary for Regulatory Activities Terminology; DOI:; Last edited: Feb. 22, 2018, 2:05 p.m.; Last accessed: Nov 14 2018 9:46 p.m.

This record is maintained by MedDRAMSSO

Record updated: Aug. 4, 2016, 11:46 a.m. by The FAIRsharing Team.



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The use of a medical dictionary for regulatory activities terminology (MedDRA) in prescription-event monitoring in Japan (J-PEM).

Yokotsuka M,Aoyama M,Kubota K
Int J Med Inform 2000

View Paper (PubMed)

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Implementing Databases (2)
Orphanet is the reference resource for information on rare diseases and orphan drugs for all publics. Its aim is to contribute to the improvement of the diagnosis, care and treatment of patients with rare diseases. Orphanet maintains the Orphanet nomenclature, essential for interoperability, and the Orphanet Rare Disease Ontology (ORDO).

European Union Drug Regulating Authorities Clinical Trials
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC.

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