HL7 Terminology (THO)
7.0.0 - publication International flag

HL7 Terminology (THO), published by HL7 International - Vocabulary Work Group. This guide is not an authorized publication; it is the continuous build for version 7.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/UTG/ and changes regularly. See the Directory of published versions

Medical Dictionary for Regulatory Activities Metadata Record

Metadata Record Information Version 20251031
Maintained By HL7 Terminology Services Management Group (TSMG)
Last Updated Date 31 October 2025
Responsible Organizations International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Roles
  • Code System Owner
  • Code System Maintainer (Steward)
  • Code System Publisher
Website https://ich.org/
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Code System Names Formal name Medical Dictionary for Regulatory Activities
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Code System Technical Identifiers Identification Record
TSMG-endorsed URI https://www.meddra.org
TSMG-endorsed OID 2.16.840.1.113883.6.163
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Description
MedDRA is a multilingual standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use. MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle (i.e., from clinical trials to post-marketing surveillance).#13; MedDRA is structured as a five level hierarchy. System Organ Classes (SOCs) are the broadest terms (e.g., Cardiac disorders, Investigations). The lowest level of the terminology is the Lowest Level Term (LLT) level.
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