HL7 Terminology (THO)
5.5.0 - Publication International flag

This page is part of the HL7 Terminology (v5.5.0: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

CodeSystem: Medical Dictionary for Regulatory Activities

Official URL: https://www.meddra.org Version: 3.0.0
Active as of 2023-06-14 Responsible: MedDRA Maintenance and Support Services Organization (MedDRA MSSO); Mr. Patrick Revelle; MSSO Director Computable Name: MedDRA
Other Identifiers: urn:ietf:rfc:3986#Uniform Resource Identifier (URI)#urn:oid:2.16.840.1.113883.6.163

Copyright/Legal: Please see https://www.meddra.org/legal-mentions. For information about special licensing, see https://www.meddra.org/subscription/special-licences

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.

This Code system is referenced in the content logical definition of the following value sets:

  • This CodeSystem is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

This case-sensitive code system https://www.meddra.org defines codes, but no codes are represented here


History

DateActionAuthorCustodianComment
2023-06-20reviseJessica BotaTSMGUpdated MedDRA Code System and Naming System per HTA; up-202
2022-07-22reviseJessica BotaTSMGAdd default value of TRUE for code systems missing caseSensitive element unless otherwise specified; UP-322