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

• Narrative Content
• XML
• JSON

: Specification Status Terminology - JSON Representation

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{
  "resourceType" : "ValueSet",
  "id" : "pqcmc-specification-status-terminology",
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet pqcmc-specification-status-terminology</b></p><a name=\"pqcmc-specification-status-terminology\"> </a><a name=\"hcpqcmc-specification-status-terminology\"> </a><a name=\"pqcmc-specification-status-terminology-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C25425</td><td>Approved</td></tr><tr><td>C48660</td><td>Not Applicable</td></tr><tr><td>C134011</td><td>Not Approved</td></tr><tr><td>C134012</td><td>Reported in a CBE or AR</td></tr><tr><td>C134010</td><td>Tentatively Approved</td></tr></table></li></ul></div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode" : "brr"
    }
  ],
  "url" : "http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-specification-status-terminology",
  "identifier" : [
    {
      "system" : "urn:ietf:rfc:3986",
      "value" : "urn:oid:2.16.840.1.113883.4.642.40.36.48.23"
    }
  ],
  "version" : "2.0.0-ballot",
  "name" : "PqcmcSpecificationStatusTerminology",
  "title" : "Specification Status Terminology",
  "status" : "active",
  "experimental" : false,
  "date" : "2024-12-04T20:50:29+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" : "Terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "urn:iso:std:iso:3166",
          "code" : "US",
          "display" : "United States of America"
        }
      ]
    }
  ],
  "compose" : {
    "include" : [
      {
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "concept" : [
          {
            "code" : "C25425",
            "display" : "Approved"
          },
          {
            "code" : "C48660",
            "display" : "Not Applicable"
          },
          {
            "code" : "C134011",
            "display" : "Not Approved"
          },
          {
            "code" : "C134012",
            "display" : "Reported in a CBE or AR"
          },
          {
            "code" : "C134010",
            "display" : "Tentatively Approved"
          }
        ]
      }
    ]
  }
}