Regulatory Correspondence, published by Gravitate Health and HL7 Vulcan. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/rfi-ig/ and changes regularly. See the Directory of published versions

• Narrative Content
• XML
• JSON
• TTL

: RFICategoryAndSubcategory - XML Representation

Draft as of 2025-06-19

Raw xml | Download

<ValueSet xmlns="http://hl7.org/fhir">
  <id value="rfi-category-subcategory"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet rfi-category-subcategory</b></p><a name="rfi-category-subcategory"> </a><a name="hcrfi-category-subcategory"> </a><p>This value set includes codes based on the following rules:</p><ul><li>Include these codes as defined in <code>http://hl7.org/fhir/rfi-category</code><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>Administrative</td><td>Administrative</td></tr><tr><td>Labeling</td><td>Labeling</td></tr><tr><td>CMC</td><td>CMC</td></tr><tr><td>Clinical</td><td>Clinical</td></tr><tr><td>Non-clinical</td><td>Non-clinical</td></tr></table></li><li>Include these codes as defined in <code>http://hl7.org/fhir/rfi-subcategory</code><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>ApplicationForm</td><td>Application Form</td></tr><tr><td>AdministrativeDetails</td><td>Administrative Details</td></tr><tr><td>ProposedLabeling</td><td>Proposed Labeling</td></tr><tr><td>RiskManagement</td><td>Risk Management</td></tr><tr><td>DrugSubstance</td><td>Drug Substance</td></tr><tr><td>Stability</td><td>Stability</td></tr><tr><td>Bioequivalence</td><td>Bioequivalence</td></tr><tr><td>ClinicalStudyReports</td><td>Clinical Study Reports</td></tr><tr><td>Toxicology</td><td>Toxicology</td></tr><tr><td>Pharmacology</td><td>Pharmacology</td></tr></table></li></ul></div>
  </text>
  <url value="http://hl7.org/fhir/ValueSet/rfi-category-subcategory"/>
  <version value="0.1.0"/>
  <name value="RFICategoryAndSubcategory"/>
  <status value="draft"/>
  <date value="2025-06-19T00:08:28+00:00"/>
  <publisher value="Gravitate Health and HL7 Vulcan"/>
  <contact>
    <name value="Gravitate Health and HL7 Vulcan"/>
    <telecom>
      <system value="url"/>
      <value value="https://www.gravitatehealth.eu/"/>
    </telecom>
  </contact>
  <description
               value="Categories and sub-categories for RFI questions, aligned to ICH CTD headings."/>
  <compose>
    <include>
      <system value="http://hl7.org/fhir/rfi-category"/>
      <concept>
        <code value="Administrative"/>
        <display value="Administrative"/>
      </concept>
      <concept>
        <code value="Labeling"/>
        <display value="Labeling"/>
      </concept>
      <concept>
        <code value="CMC"/>
        <display value="CMC"/>
      </concept>
      <concept>
        <code value="Clinical"/>
        <display value="Clinical"/>
      </concept>
      <concept>
        <code value="Non-clinical"/>
        <display value="Non-clinical"/>
      </concept>
    </include>
    <include>
      <system value="http://hl7.org/fhir/rfi-subcategory"/>
      <concept>
        <code value="ApplicationForm"/>
        <display value="Application Form"/>
      </concept>
      <concept>
        <code value="AdministrativeDetails"/>
        <display value="Administrative Details"/>
      </concept>
      <concept>
        <code value="ProposedLabeling"/>
        <display value="Proposed Labeling"/>
      </concept>
      <concept>
        <code value="RiskManagement"/>
        <display value="Risk Management"/>
      </concept>
      <concept>
        <code value="DrugSubstance"/>
        <display value="Drug Substance"/>
      </concept>
      <concept>
        <code value="Stability"/>
        <display value="Stability"/>
      </concept>
      <concept>
        <code value="Bioequivalence"/>
        <display value="Bioequivalence"/>
      </concept>
      <concept>
        <code value="ClinicalStudyReports"/>
        <display value="Clinical Study Reports"/>
      </concept>
      <concept>
        <code value="Toxicology"/>
        <display value="Toxicology"/>
      </concept>
      <concept>
        <code value="Pharmacology"/>
        <display value="Pharmacology"/>
      </concept>
    </include>
  </compose>
</ValueSet>