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 1.0.0 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

: Specification Status Terminology - XML Representation

Draft as of 2024-11-13

Raw xml | Download


<ValueSet xmlns="http://hl7.org/fhir">
  <id value="pqcmc-specification-status-terminology"/>
  <text>
    <status value="generated"/>
    <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="CodeSystem-cmc-ncit-dummy.html"><code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C25425">C25425</a></td><td>Approved</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C48660">C48660</a></td><td>Not Applicable</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C134011">C134011</a></td><td>Not Approved</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C134012">C134012</a></td><td>Reported in a CBE or AR</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C134010">C134010</a></td><td>Tentatively Approved</td></tr></table></li></ul></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/ValueSet/pqcmc-specification-status-terminology"/>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.23"/>
  </identifier>
  <version value="1.0.0"/>
  <name value="PqcmcSpecificationStatusTerminology"/>
  <title value="Specification Status Terminology"/>
  <status value="draft"/>
  <experimental value="false"/>
  <date value="2024-11-13T04:45:16+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="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 value="urn:iso:std:iso:3166"/>
      <code value="US"/>
      <display value="United States of America"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <system
              value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
      <concept>
        <code value="C25425"/>
        <display value="Approved"/>
      </concept>
      <concept>
        <code value="C48660"/>
        <display value="Not Applicable"/>
      </concept>
      <concept>
        <code value="C134011"/>
        <display value="Not Approved"/>
      </concept>
      <concept>
        <code value="C134012"/>
        <display value="Reported in a CBE or AR"/>
      </concept>
      <concept>
        <code value="C134010"/>
        <display value="Tentatively Approved"/>
      </concept>
    </include>
  </compose>
</ValueSet>