Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

: PQ-CMC-FDA NCIt Hieararchy Supplement - XML Representation

Draft as of 2024-12-04

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<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="cmc-hierarchy-supplement"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem cmc-hierarchy-supplement</b></p><a name="cmc-hierarchy-supplement"> </a><a name="hccmc-hierarchy-supplement"> </a><a name="cmc-hierarchy-supplement-en-US"> </a><p><b>Properties</b></p><p><b>This code system defines the following properties for its concepts</b></p><table class="grid"><tr><td><b>Name</b></td><td><b>Code</b></td><td><b>URI</b></td><td><b>Type</b></td><td><b>Description</b></td></tr><tr><td>Child</td><td>child</td><td>http://hl7.org/fhir/concept-properties#child</td><td>code</td><td>Defines which codes are children</td></tr></table><p><b>Concepts</b></p><p>This code system <code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-hierarchy-supplement</code> defines properties on the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Child</b></td></tr><tr><td><a style="white-space:nowrap" href="https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?code=C60819">C60819</a><a name="cmc-hierarchy-supplement-C60819"> </a></td><td>C204845, C205001, C81183, C205003, C205007, C205015, C205018, C205020, C205028, C62352, C171277, C205038, C64858, C205006</td></tr><tr><td><a style="white-space:nowrap" href="https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?code=C134250">C134250</a><a name="cmc-hierarchy-supplement-C134250"> </a></td><td>C205004, C205019, C134115, C205050</td></tr><tr><td><a style="white-space:nowrap" href="https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?code=C205026">C205026</a><a name="cmc-hierarchy-supplement-C205026"> </a></td><td>C138990, C139027, C134262, C134261</td></tr><tr><td><a style="white-space:nowrap" href="https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?code=C193381">C193381</a><a name="cmc-hierarchy-supplement-C193381"> </a></td><td>C205024</td></tr><tr><td><a style="white-space:nowrap" href="https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?code=C25483">C25483</a><a name="cmc-hierarchy-supplement-C25483"> </a></td><td>C205022, C205017, C205209, C205053, C205021, C205016, C205206, C205045, C205036, C205011, C205010, C205009, C205037, C205025, C205034, C205033, C205035, C205005, C205044, C205043, C205042</td></tr><tr><td><a style="white-space:nowrap" href="https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?code=C18951">C18951</a><a name="cmc-hierarchy-supplement-C18951"> </a></td><td>C16643, C205054, C205031, C205002, C205008</td></tr><tr><td><a style="white-space:nowrap" href="https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?code=C204971">C204971</a><a name="cmc-hierarchy-supplement-C204971"> </a></td><td>C205039, C205040, C205052, C205047, C205048, C205051, C205014, C204890, C134254, C134002</td></tr><tr><td><a style="white-space:nowrap" href="https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?code=C45298">C45298</a><a name="cmc-hierarchy-supplement-C45298"> </a></td><td>C154598</td></tr><tr><td><a style="white-space:nowrap" href="https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?code=C45300">C45300</a><a name="cmc-hierarchy-supplement-C45300"> </a></td><td>C154433, C154605</td></tr></table></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <url
       value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-hierarchy-supplement"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.36.16.7"/>
  </identifier>
  <version value="2.0.0-ballot"/>
  <name value="NCItHierarchySupplement"/>
  <title value="PQ-CMC-FDA NCIt Hieararchy Supplement"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2024-12-04T20:50:29+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="brr@lists.HL7.org"/>
    </telecom>
  </contact>
  <description
               value="Provides hierarchical relationships for value sets as a CodeSystem supplement to the NCI Thesaurus (NCIt) "/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="US"/>
      <display value="United States of America"/>
    </coding>
  </jurisdiction>
  <copyright
             value="PQ-CMC-FDA Temporary Codes are either in the NCI Thesaurus (NCIt) or are in the process of being included in NCIt. When all codes are in NCIt, they will migrate to the HL7 Terminology (THO). License Note Unless otherwise indicated, all text within NCI products is free of copyright and may be reused without our permission. Credit the National Cancer Institute as the source. For more licensing information see: [https://www.cancer.gov/policies/copyright-reuse](https://www.cancer.gov/policies/copyright-reuse)"/>
  <hierarchyMeaning value="is-a"/>
  <content value="supplement"/>
  <supplements value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
  <property>
    <code value="child"/>
    <uri value="http://hl7.org/fhir/concept-properties#child"/>
    <description value="Defines which codes are children"/>
    <type value="code"/>
  </property>
  <concept>
    <code value="C60819"/>
    <property>
      <code value="child"/>
      <valueCode value="C204845"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205001"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C81183"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205003"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205007"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205015"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205018"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205020"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205028"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C62352"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C171277"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205038"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C64858"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205006"/>
    </property>
  </concept>
  <concept>
    <code value="C134250"/>
    <property>
      <code value="child"/>
      <valueCode value="C205004"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205019"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C134115"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205050"/>
    </property>
  </concept>
  <concept>
    <code value="C205026"/>
    <property>
      <code value="child"/>
      <valueCode value="C138990"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C139027"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C134262"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C134261"/>
    </property>
  </concept>
  <concept>
    <code value="C193381"/>
    <property>
      <code value="child"/>
      <valueCode value="C205024"/>
    </property>
  </concept>
  <concept>
    <code value="C25483"/>
    <property>
      <code value="child"/>
      <valueCode value="C205022"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205017"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205209"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205053"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205021"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205016"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205206"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205045"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205036"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205011"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205010"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205009"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205037"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205025"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205034"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205033"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205035"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205005"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205044"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205043"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205042"/>
    </property>
  </concept>
  <concept>
    <code value="C18951"/>
    <property>
      <code value="child"/>
      <valueCode value="C16643"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205054"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205031"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205002"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205008"/>
    </property>
  </concept>
  <concept>
    <code value="C204971"/>
    <property>
      <code value="child"/>
      <valueCode value="C205039"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205040"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205052"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205047"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205048"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205051"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C205014"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C204890"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C134254"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C134002"/>
    </property>
  </concept>
  <concept>
    <code value="C45298"/>
    <property>
      <code value="child"/>
      <valueCode value="C154598"/>
    </property>
  </concept>
  <concept>
    <code value="C45300"/>
    <property>
      <code value="child"/>
      <valueCode value="C154433"/>
    </property>
    <property>
      <code value="child"/>
      <valueCode value="C154605"/>
    </property>
  </concept>
</CodeSystem>