HL7 Terminology (THO)
6.1.0 - Publication International flag

This page is part of the HL7 Terminology (v6.1.0: Release) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

: Medical Dictionary for Regulatory Activities - XML Representation

Active as of 2023-06-15

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<NamingSystem xmlns="http://hl7.org/fhir">
  <id value="mdr"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: NamingSystem mdr</b></p><a name="mdr"> </a><a name="hcmdr"> </a><a name="mdr-en-US"> </a><h3>Summary</h3><table class="grid"><tr><td>Defining URL</td><td>http://terminology.hl7.org/NamingSystem/mdr</td></tr><tr><td>Version</td><td>3.0.0</td></tr><tr><td>Name</td><td>MedDRA</td></tr><tr><td>Title</td><td>Medical Dictionary for Regulatory Activities</td></tr><tr><td>Status</td><td>active</td></tr><tr><td>Definition</td><td><div><p>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;</p>
<p>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.</p>
</div></td></tr><tr><td>Publisher</td><td>MedDRA Maintenance and Support Services Organization (MedDRA MSSO); Mr. Patrick Revelle; MSSO Director</td></tr></table><h3>Identifiers</h3><table class="grid"><tr><td><b>Type</b></td><td><b>Value</b></td><td><b>Preferred</b></td></tr><tr><td>OID</td><td>2.16.840.1.113883.6.163</td><td>true</td></tr><tr><td>URI</td><td>https://www.meddra.org</td><td>true</td></tr><tr><td>URI</td><td>http://terminology.hl7.org/CodeSystem/mdr</td><td>false</td></tr></table></div>
  </text>
  <url value="http://terminology.hl7.org/NamingSystem/mdr"/>
  <version value="3.0.0"/>
  <name value="MedDRA"/>
  <title value="Medical Dictionary for Regulatory Activities"/>
  <status value="active"/>
  <kind value="codesystem"/>
  <date value="2023-06-15T00:00:00-04:00"/>
  <publisher
             value="MedDRA Maintenance and Support Services Organization (MedDRA MSSO); Mr. Patrick Revelle; MSSO Director"/>
  <contact>
    <name
          value="International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)"/>
    <telecom>
      <system value="url"/>
      <value value="https://www.ich.org/page/contact"/>
    </telecom>
  </contact>
  <responsible
               value="MedDRA Maintenance and Support Services Organization (MedDRA MSSO)"/>
  <description
               value="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."/>
  <uniqueId>
    <type value="oid"/>
    <value value="2.16.840.1.113883.6.163"/>
    <preferred value="true"/>
  </uniqueId>
  <uniqueId>
    <type value="uri"/>
    <value value="https://www.meddra.org"/>
    <preferred value="true"/>
  </uniqueId>
  <uniqueId>
    <type value="uri"/>
    <value value="http://terminology.hl7.org/CodeSystem/mdr"/>
    <preferred value="false"/>
  </uniqueId>
</NamingSystem>