This page is part of the HL7 Terminology (v5.4.0: Release) based on FHIR R4. 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
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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"><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>
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<valueString value="Medical Dictionary for Regulatory Activities"/>
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<name value="MedDRA"/>
<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)"/>
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<value value="https://www.ich.org/page/contact"/>
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<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."/>
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<value value="https://www.meddra.org"/>
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<value value="http://terminology.hl7.org/CodeSystem/mdr"/>
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</NamingSystem>
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