Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 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 Hierarchy Supplement - JSON Representation

Page standards status: Trial-use | Maturity Level: 2

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    {
      "resourceType" : "CodeSystem",
      "id" : "cmc-hierarchy-supplement",
      "text" : {
        "status" : "generated",
        "div" : "<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><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 supplement <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>"
      },
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
          "valueCode" : "brr"
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
          "valueInteger" : 2,
          "_valueInteger" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
                "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
              }
            ]
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
          "valueCode" : "trial-use",
          "_valueCode" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
                "valueCanonical" : "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"
              }
            ]
          }
        }
      ],
      "url" : "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-hierarchy-supplement",
      "identifier" : [
        {
          "system" : "urn:ietf:rfc:3986",
          "value" : "urn:oid:2.16.840.1.113883.4.642.40.36.16.7"
        }
      ],
      "version" : "2.0.0",
      "name" : "NCItHierarchySupplement",
      "title" : "PQ-CMC-FDA NCIt Hierarchy Supplement",
      "status" : "active",
      "experimental" : false,
      "date" : "2025-07-03T13:07:08+00:00",
      "publisher" : "HL7 International / Biomedical Research and Regulation",
      "contact" : [
        {
          "name" : "HL7 International / Biomedical Research and Regulation",
          "telecom" : [
            {
              "system" : "url",
              "value" : "http://www.hl7.org/Special/committees/rcrim"
            },
            {
              "system" : "email",
              "value" : "brr@lists.HL7.org"
            }
          ]
        }
      ],
      "description" : "Provides hierarchical relationships for value sets as a CodeSystem supplement to the NCI Thesaurus (NCIt) ",
      "jurisdiction" : [
        {
          "coding" : [
            {
              "system" : "urn:iso:std:iso:3166",
              "code" : "US",
              "display" : "United States of America"
            }
          ]
        }
      ],
      "copyright" : "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" : "is-a",
      "content" : "supplement",
      "supplements" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
      "property" : [
        {
          "code" : "child",
          "uri" : "http://hl7.org/fhir/concept-properties#child",
          "description" : "Defines which codes are children",
          "type" : "code"
        }
      ],
      "concept" : [
        {
          "code" : "C60819",
          "property" : [
            {
              "code" : "child",
              "valueCode" : "C204845"
            },
            {
              "code" : "child",
              "valueCode" : "C205001"
            },
            {
              "code" : "child",
              "valueCode" : "C81183"
            },
            {
              "code" : "child",
              "valueCode" : "C205003"
            },
            {
              "code" : "child",
              "valueCode" : "C205007"
            },
            {
              "code" : "child",
              "valueCode" : "C205015"
            },
            {
              "code" : "child",
              "valueCode" : "C205018"
            },
            {
              "code" : "child",
              "valueCode" : "C205020"
            },
            {
              "code" : "child",
              "valueCode" : "C205028"
            },
            {
              "code" : "child",
              "valueCode" : "C62352"
            },
            {
              "code" : "child",
              "valueCode" : "C171277"
            },
            {
              "code" : "child",
              "valueCode" : "C205038"
            },
            {
              "code" : "child",
              "valueCode" : "C64858"
            },
            {
              "code" : "child",
              "valueCode" : "C205006"
            }
          ]
        },
        {
          "code" : "C134250",
          "property" : [
            {
              "code" : "child",
              "valueCode" : "C205004"
            },
            {
              "code" : "child",
              "valueCode" : "C205019"
            },
            {
              "code" : "child",
              "valueCode" : "C134115"
            },
            {
              "code" : "child",
              "valueCode" : "C205050"
            }
          ]
        },
        {
          "code" : "C205026",
          "property" : [
            {
              "code" : "child",
              "valueCode" : "C138990"
            },
            {
              "code" : "child",
              "valueCode" : "C139027"
            },
            {
              "code" : "child",
              "valueCode" : "C134262"
            },
            {
              "code" : "child",
              "valueCode" : "C134261"
            }
          ]
        },
        {
          "code" : "C193381",
          "property" : [
            {
              "code" : "child",
              "valueCode" : "C205024"
            }
          ]
        },
        {
          "code" : "C25483",
          "property" : [
            {
              "code" : "child",
              "valueCode" : "C205022"
            },
            {
              "code" : "child",
              "valueCode" : "C205017"
            },
            {
              "code" : "child",
              "valueCode" : "C205209"
            },
            {
              "code" : "child",
              "valueCode" : "C205053"
            },
            {
              "code" : "child",
              "valueCode" : "C205021"
            },
            {
              "code" : "child",
              "valueCode" : "C205016"
            },
            {
              "code" : "child",
              "valueCode" : "C205206"
            },
            {
              "code" : "child",
              "valueCode" : "C205045"
            },
            {
              "code" : "child",
              "valueCode" : "C205036"
            },
            {
              "code" : "child",
              "valueCode" : "C205011"
            },
            {
              "code" : "child",
              "valueCode" : "C205010"
            },
            {
              "code" : "child",
              "valueCode" : "C205009"
            },
            {
              "code" : "child",
              "valueCode" : "C205037"
            },
            {
              "code" : "child",
              "valueCode" : "C205025"
            },
            {
              "code" : "child",
              "valueCode" : "C205034"
            },
            {
              "code" : "child",
              "valueCode" : "C205033"
            },
            {
              "code" : "child",
              "valueCode" : "C205035"
            },
            {
              "code" : "child",
              "valueCode" : "C205005"
            },
            {
              "code" : "child",
              "valueCode" : "C205044"
            },
            {
              "code" : "child",
              "valueCode" : "C205043"
            },
            {
              "code" : "child",
              "valueCode" : "C205042"
            }
          ]
        },
        {
          "code" : "C18951",
          "property" : [
            {
              "code" : "child",
              "valueCode" : "C16643"
            },
            {
              "code" : "child",
              "valueCode" : "C205054"
            },
            {
              "code" : "child",
              "valueCode" : "C205031"
            },
            {
              "code" : "child",
              "valueCode" : "C205002"
            },
            {
              "code" : "child",
              "valueCode" : "C205008"
            }
          ]
        },
        {
          "code" : "C204971",
          "property" : [
            {
              "code" : "child",
              "valueCode" : "C205039"
            },
            {
              "code" : "child",
              "valueCode" : "C205040"
            },
            {
              "code" : "child",
              "valueCode" : "C205052"
            },
            {
              "code" : "child",
              "valueCode" : "C205047"
            },
            {
              "code" : "child",
              "valueCode" : "C205048"
            },
            {
              "code" : "child",
              "valueCode" : "C205051"
            },
            {
              "code" : "child",
              "valueCode" : "C205014"
            },
            {
              "code" : "child",
              "valueCode" : "C204890"
            },
            {
              "code" : "child",
              "valueCode" : "C134254"
            },
            {
              "code" : "child",
              "valueCode" : "C134002"
            }
          ]
        },
        {
          "code" : "C45298",
          "property" : [
            {
              "code" : "child",
              "valueCode" : "C154598"
            }
          ]
        },
        {
          "code" : "C45300",
          "property" : [
            {
              "code" : "child",
              "valueCode" : "C154433"
            },
            {
              "code" : "child",
              "valueCode" : "C154605"
            }
          ]
        }
      ]
    }