API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
API for the Exchange of Medicinal Product Information (APIX), published by Gravitate Health Project. 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/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions
| Active as of 2025-11-24 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem ctd-section</b></p><a name="ctd-section"> </a><a name="hcctd-section"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td style="white-space:nowrap">1.0<a name="ctd-section-1.460"> </a></td><td>Cover Letter</td></tr><tr><td style="white-space:nowrap">1.2<a name="ctd-section-1.462"> </a></td><td>Administrative Information</td></tr><tr><td style="white-space:nowrap">1.3.1<a name="ctd-section-1.463.461"> </a></td><td>SPC, Labelling and Package Leaflet</td></tr><tr><td style="white-space:nowrap">1.3.2<a name="ctd-section-1.463.462"> </a></td><td>Mock-ups</td></tr><tr><td style="white-space:nowrap">1.3.3<a name="ctd-section-1.463.463"> </a></td><td>Specimens</td></tr><tr><td style="white-space:nowrap">1.4<a name="ctd-section-1.464"> </a></td><td>Information about the Experts</td></tr><tr><td style="white-space:nowrap">1.8.1<a name="ctd-section-1.468.461"> </a></td><td>Risk Management Plan</td></tr><tr><td style="white-space:nowrap">1.9<a name="ctd-section-1.469"> </a></td><td>Pharmacovigilance System</td></tr><tr><td style="white-space:nowrap">2.2<a name="ctd-section-2.462"> </a></td><td>Introduction</td></tr><tr><td style="white-space:nowrap">2.3<a name="ctd-section-2.463"> </a></td><td>Quality Overall Summary</td></tr><tr><td style="white-space:nowrap">2.4<a name="ctd-section-2.464"> </a></td><td>Nonclinical Overview</td></tr><tr><td style="white-space:nowrap">2.5<a name="ctd-section-2.465"> </a></td><td>Clinical Overview</td></tr><tr><td style="white-space:nowrap">2.6<a name="ctd-section-2.466"> </a></td><td>Nonclinical Summary</td></tr><tr><td style="white-space:nowrap">2.7<a name="ctd-section-2.467"> </a></td><td>Clinical Summary</td></tr><tr><td style="white-space:nowrap">3.2.S.1<a name="ctd-section-3.462.46S.461"> </a></td><td>General Information (Drug Substance)</td></tr><tr><td style="white-space:nowrap">3.2.S.1.1<a name="ctd-section-3.462.46S.461.461"> </a></td><td>Nomenclature</td></tr><tr><td style="white-space:nowrap">3.2.S.1.2<a name="ctd-section-3.462.46S.461.462"> </a></td><td>Structure</td></tr><tr><td style="white-space:nowrap">3.2.S.1.3<a name="ctd-section-3.462.46S.461.463"> </a></td><td>General Properties</td></tr><tr><td style="white-space:nowrap">3.2.S.2<a name="ctd-section-3.462.46S.462"> </a></td><td>Manufacture (Drug Substance)</td></tr><tr><td style="white-space:nowrap">3.2.S.3<a name="ctd-section-3.462.46S.463"> </a></td><td>Characterisation (Drug Substance)</td></tr><tr><td style="white-space:nowrap">3.2.S.4<a name="ctd-section-3.462.46S.464"> </a></td><td>Control of Drug Substance</td></tr><tr><td style="white-space:nowrap">3.2.S.5<a name="ctd-section-3.462.46S.465"> </a></td><td>Reference Standards or Materials</td></tr><tr><td style="white-space:nowrap">3.2.S.6<a name="ctd-section-3.462.46S.466"> </a></td><td>Container Closure System</td></tr><tr><td style="white-space:nowrap">3.2.S.7<a name="ctd-section-3.462.46S.467"> </a></td><td>Stability (Drug Substance)</td></tr><tr><td style="white-space:nowrap">3.2.P.1<a name="ctd-section-3.462.46P.461"> </a></td><td>Description and Composition of the Drug Product</td></tr><tr><td style="white-space:nowrap">3.2.P.2<a name="ctd-section-3.462.46P.462"> </a></td><td>Pharmaceutical Development</td></tr><tr><td style="white-space:nowrap">3.2.P.3<a name="ctd-section-3.462.46P.463"> </a></td><td>Manufacture (Drug Product)</td></tr><tr><td style="white-space:nowrap">3.2.P.4<a name="ctd-section-3.462.46P.464"> </a></td><td>Control of Excipients</td></tr><tr><td style="white-space:nowrap">3.2.P.5<a name="ctd-section-3.462.46P.465"> </a></td><td>Control of Drug Product</td></tr><tr><td style="white-space:nowrap">3.2.P.5.1<a name="ctd-section-3.462.46P.465.461"> </a></td><td>Specification(s)</td></tr><tr><td style="white-space:nowrap">3.2.P.5.6<a name="ctd-section-3.462.46P.465.466"> </a></td><td>Justification of Specification(s)</td></tr><tr><td style="white-space:nowrap">3.2.P.8<a name="ctd-section-3.462.46P.468"> </a></td><td>Stability (Drug Product)</td></tr><tr><td style="white-space:nowrap">3.2.P.8.1<a name="ctd-section-3.462.46P.468.461"> </a></td><td>Stability Summary and Conclusion</td></tr><tr><td style="white-space:nowrap">3.2.P.8.2<a name="ctd-section-3.462.46P.468.462"> </a></td><td>Post-approval Stability Protocol and Commitment</td></tr><tr><td style="white-space:nowrap">3.2.P.8.3<a name="ctd-section-3.462.46P.468.463"> </a></td><td>Stability Data</td></tr><tr><td style="white-space:nowrap">3.2.A.1<a name="ctd-section-3.462.46A.461"> </a></td><td>Facilities and Equipment</td></tr><tr><td style="white-space:nowrap">3.2.A.2<a name="ctd-section-3.462.46A.462"> </a></td><td>Adventitious Agents Safety Evaluation</td></tr><tr><td style="white-space:nowrap">3.2.A.3<a name="ctd-section-3.462.46A.463"> </a></td><td>Excipients</td></tr><tr><td style="white-space:nowrap">3.2.R<a name="ctd-section-3.462.46R"> </a></td><td>Regional Information</td></tr><tr><td style="white-space:nowrap">4.1<a name="ctd-section-4.461"> </a></td><td>Table of Contents (Nonclinical)</td></tr><tr><td style="white-space:nowrap">4.2<a name="ctd-section-4.462"> </a></td><td>Study Reports (Nonclinical)</td></tr><tr><td style="white-space:nowrap">5.1<a name="ctd-section-5.461"> </a></td><td>Table of Contents (Clinical)</td></tr><tr><td style="white-space:nowrap">5.2<a name="ctd-section-5.462"> </a></td><td>Tabular Listing of All Clinical Studies</td></tr><tr><td style="white-space:nowrap">5.3<a name="ctd-section-5.463"> </a></td><td>Clinical Study Reports</td></tr><tr><td style="white-space:nowrap">5.3.5<a name="ctd-section-5.463.465"> </a></td><td>Reports of Efficacy and Safety Studies</td></tr><tr><td style="white-space:nowrap">5.3.5.1<a name="ctd-section-5.463.465.461"> </a></td><td>Study Reports of Controlled Clinical Studies</td></tr><tr><td style="white-space:nowrap">5.3.5.3<a name="ctd-section-5.463.465.463"> </a></td><td>Reports of Analysis of Data from More than One Study</td></tr></table></div>
</text>
<url value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
<version value="0.1.0"/>
<name value="APIX_CTD_Section"/>
<title value="APIX CTD/eCTD Section Code System"/>
<status value="active"/>
<experimental value="false"/>
<date value="2025-11-24"/>
<publisher value="Gravitate Health Project"/>
<contact>
<name value="Gravitate Health Project"/>
<telecom>
<system value="url"/>
<value value="https://www.gravitatehealth.eu/"/>
</telecom>
</contact>
<description
value="Code system defining all relevant CTD/eCTD section codes used in APIX regulatory submissions to EMA, FDA, PMDA and other agencies. Based on ICH M4 guidelines."/>
<caseSensitive value="true"/>
<content value="complete"/>
<concept>
<code value="1.0"/>
<display value="Cover Letter"/>
</concept>
<concept>
<code value="1.2"/>
<display value="Administrative Information"/>
</concept>
<concept>
<code value="1.3.1"/>
<display value="SPC, Labelling and Package Leaflet"/>
</concept>
<concept>
<code value="1.3.2"/>
<display value="Mock-ups"/>
</concept>
<concept>
<code value="1.3.3"/>
<display value="Specimens"/>
</concept>
<concept>
<code value="1.4"/>
<display value="Information about the Experts"/>
</concept>
<concept>
<code value="1.8.1"/>
<display value="Risk Management Plan"/>
</concept>
<concept>
<code value="1.9"/>
<display value="Pharmacovigilance System"/>
</concept>
<concept>
<code value="2.2"/>
<display value="Introduction"/>
</concept>
<concept>
<code value="2.3"/>
<display value="Quality Overall Summary"/>
</concept>
<concept>
<code value="2.4"/>
<display value="Nonclinical Overview"/>
</concept>
<concept>
<code value="2.5"/>
<display value="Clinical Overview"/>
</concept>
<concept>
<code value="2.6"/>
<display value="Nonclinical Summary"/>
</concept>
<concept>
<code value="2.7"/>
<display value="Clinical Summary"/>
</concept>
<concept>
<code value="3.2.S.1"/>
<display value="General Information (Drug Substance)"/>
</concept>
<concept>
<code value="3.2.S.1.1"/>
<display value="Nomenclature"/>
</concept>
<concept>
<code value="3.2.S.1.2"/>
<display value="Structure"/>
</concept>
<concept>
<code value="3.2.S.1.3"/>
<display value="General Properties"/>
</concept>
<concept>
<code value="3.2.S.2"/>
<display value="Manufacture (Drug Substance)"/>
</concept>
<concept>
<code value="3.2.S.3"/>
<display value="Characterisation (Drug Substance)"/>
</concept>
<concept>
<code value="3.2.S.4"/>
<display value="Control of Drug Substance"/>
</concept>
<concept>
<code value="3.2.S.5"/>
<display value="Reference Standards or Materials"/>
</concept>
<concept>
<code value="3.2.S.6"/>
<display value="Container Closure System"/>
</concept>
<concept>
<code value="3.2.S.7"/>
<display value="Stability (Drug Substance)"/>
</concept>
<concept>
<code value="3.2.P.1"/>
<display value="Description and Composition of the Drug Product"/>
</concept>
<concept>
<code value="3.2.P.2"/>
<display value="Pharmaceutical Development"/>
</concept>
<concept>
<code value="3.2.P.3"/>
<display value="Manufacture (Drug Product)"/>
</concept>
<concept>
<code value="3.2.P.4"/>
<display value="Control of Excipients"/>
</concept>
<concept>
<code value="3.2.P.5"/>
<display value="Control of Drug Product"/>
</concept>
<concept>
<code value="3.2.P.5.1"/>
<display value="Specification(s)"/>
</concept>
<concept>
<code value="3.2.P.5.6"/>
<display value="Justification of Specification(s)"/>
</concept>
<concept>
<code value="3.2.P.8"/>
<display value="Stability (Drug Product)"/>
</concept>
<concept>
<code value="3.2.P.8.1"/>
<display value="Stability Summary and Conclusion"/>
</concept>
<concept>
<code value="3.2.P.8.2"/>
<display value="Post-approval Stability Protocol and Commitment"/>
</concept>
<concept>
<code value="3.2.P.8.3"/>
<display value="Stability Data"/>
</concept>
<concept>
<code value="3.2.A.1"/>
<display value="Facilities and Equipment"/>
</concept>
<concept>
<code value="3.2.A.2"/>
<display value="Adventitious Agents Safety Evaluation"/>
</concept>
<concept>
<code value="3.2.A.3"/>
<display value="Excipients"/>
</concept>
<concept>
<code value="3.2.R"/>
<display value="Regional Information"/>
</concept>
<concept>
<code value="4.1"/>
<display value="Table of Contents (Nonclinical)"/>
</concept>
<concept>
<code value="4.2"/>
<display value="Study Reports (Nonclinical)"/>
</concept>
<concept>
<code value="5.1"/>
<display value="Table of Contents (Clinical)"/>
</concept>
<concept>
<code value="5.2"/>
<display value="Tabular Listing of All Clinical Studies"/>
</concept>
<concept>
<code value="5.3"/>
<display value="Clinical Study Reports"/>
</concept>
<concept>
<code value="5.3.5"/>
<display value="Reports of Efficacy and Safety Studies"/>
</concept>
<concept>
<code value="5.3.5.1"/>
<display value="Study Reports of Controlled Clinical Studies"/>
</concept>
<concept>
<code value="5.3.5.3"/>
<display value="Reports of Analysis of Data from More than One Study"/>
</concept>
</CodeSystem>