HL7 Terminology (THO)
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This page is part of the HL7 Terminology (v7.0.0: Release) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, 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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