APIX CTD/eCTD Section Code System - TTL Representation - API for the Exchange of Medicinal Product Information (APIX) v0.1.0

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
: APIX CTD/eCTD Section Code System - TTL Representation

Active as of 2025-11-24
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "ctd-section"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:url [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>
  ] ; # 
  fhir:version [ fhir:v "0.1.0"] ; # 
  fhir:name [ fhir:v "APIX_CTD_Section"] ; # 
  fhir:title [ fhir:v "APIX CTD/eCTD Section Code System"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v false] ; # 
  fhir:date [ fhir:v "2025-11-24"^^xsd:date] ; # 
  fhir:publisher [ fhir:v "Gravitate Health Project"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "Gravitate Health Project" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "https://www.gravitatehealth.eu/" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "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."] ; # 
  fhir:caseSensitive [ fhir:v true] ; # 
  fhir:content [ fhir:v "complete"] ; # 
  fhir:concept ( [
fhir:code [ fhir:v "1.0" ] ;
fhir:display [ fhir:v "Cover Letter" ]
  ] [
fhir:code [ fhir:v "1.2" ] ;
fhir:display [ fhir:v "Administrative Information" ]
  ] [
fhir:code [ fhir:v "1.3.1" ] ;
fhir:display [ fhir:v "SPC, Labelling and Package Leaflet" ]
  ] [
fhir:code [ fhir:v "1.3.2" ] ;
fhir:display [ fhir:v "Mock-ups" ]
  ] [
fhir:code [ fhir:v "1.3.3" ] ;
fhir:display [ fhir:v "Specimens" ]
  ] [
fhir:code [ fhir:v "1.4" ] ;
fhir:display [ fhir:v "Information about the Experts" ]
  ] [
fhir:code [ fhir:v "1.8.1" ] ;
fhir:display [ fhir:v "Risk Management Plan" ]
  ] [
fhir:code [ fhir:v "1.9" ] ;
fhir:display [ fhir:v "Pharmacovigilance System" ]
  ] [
fhir:code [ fhir:v "2.2" ] ;
fhir:display [ fhir:v "Introduction" ]
  ] [
fhir:code [ fhir:v "2.3" ] ;
fhir:display [ fhir:v "Quality Overall Summary" ]
  ] [
fhir:code [ fhir:v "2.4" ] ;
fhir:display [ fhir:v "Nonclinical Overview" ]
  ] [
fhir:code [ fhir:v "2.5" ] ;
fhir:display [ fhir:v "Clinical Overview" ]
  ] [
fhir:code [ fhir:v "2.6" ] ;
fhir:display [ fhir:v "Nonclinical Summary" ]
  ] [
fhir:code [ fhir:v "2.7" ] ;
fhir:display [ fhir:v "Clinical Summary" ]
  ] [
fhir:code [ fhir:v "3.2.S.1" ] ;
fhir:display [ fhir:v "General Information (Drug Substance)" ]
  ] [
fhir:code [ fhir:v "3.2.S.1.1" ] ;
fhir:display [ fhir:v "Nomenclature" ]
  ] [
fhir:code [ fhir:v "3.2.S.1.2" ] ;
fhir:display [ fhir:v "Structure" ]
  ] [
fhir:code [ fhir:v "3.2.S.1.3" ] ;
fhir:display [ fhir:v "General Properties" ]
  ] [
fhir:code [ fhir:v "3.2.S.2" ] ;
fhir:display [ fhir:v "Manufacture (Drug Substance)" ]
  ] [
fhir:code [ fhir:v "3.2.S.3" ] ;
fhir:display [ fhir:v "Characterisation (Drug Substance)" ]
  ] [
fhir:code [ fhir:v "3.2.S.4" ] ;
fhir:display [ fhir:v "Control of Drug Substance" ]
  ] [
fhir:code [ fhir:v "3.2.S.5" ] ;
fhir:display [ fhir:v "Reference Standards or Materials" ]
  ] [
fhir:code [ fhir:v "3.2.S.6" ] ;
fhir:display [ fhir:v "Container Closure System" ]
  ] [
fhir:code [ fhir:v "3.2.S.7" ] ;
fhir:display [ fhir:v "Stability (Drug Substance)" ]
  ] [
fhir:code [ fhir:v "3.2.P.1" ] ;
fhir:display [ fhir:v "Description and Composition of the Drug Product" ]
  ] [
fhir:code [ fhir:v "3.2.P.2" ] ;
fhir:display [ fhir:v "Pharmaceutical Development" ]
  ] [
fhir:code [ fhir:v "3.2.P.3" ] ;
fhir:display [ fhir:v "Manufacture (Drug Product)" ]
  ] [
fhir:code [ fhir:v "3.2.P.4" ] ;
fhir:display [ fhir:v "Control of Excipients" ]
  ] [
fhir:code [ fhir:v "3.2.P.5" ] ;
fhir:display [ fhir:v "Control of Drug Product" ]
  ] [
fhir:code [ fhir:v "3.2.P.5.1" ] ;
fhir:display [ fhir:v "Specification(s)" ]
  ] [
fhir:code [ fhir:v "3.2.P.5.6" ] ;
fhir:display [ fhir:v "Justification of Specification(s)" ]
  ] [
fhir:code [ fhir:v "3.2.P.8" ] ;
fhir:display [ fhir:v "Stability (Drug Product)" ]
  ] [
fhir:code [ fhir:v "3.2.P.8.1" ] ;
fhir:display [ fhir:v "Stability Summary and Conclusion" ]
  ] [
fhir:code [ fhir:v "3.2.P.8.2" ] ;
fhir:display [ fhir:v "Post-approval Stability Protocol and Commitment" ]
  ] [
fhir:code [ fhir:v "3.2.P.8.3" ] ;
fhir:display [ fhir:v "Stability Data" ]
  ] [
fhir:code [ fhir:v "3.2.A.1" ] ;
fhir:display [ fhir:v "Facilities and Equipment" ]
  ] [
fhir:code [ fhir:v "3.2.A.2" ] ;
fhir:display [ fhir:v "Adventitious Agents Safety Evaluation" ]
  ] [
fhir:code [ fhir:v "3.2.A.3" ] ;
fhir:display [ fhir:v "Excipients" ]
  ] [
fhir:code [ fhir:v "3.2.R" ] ;
fhir:display [ fhir:v "Regional Information" ]
  ] [
fhir:code [ fhir:v "4.1" ] ;
fhir:display [ fhir:v "Table of Contents (Nonclinical)" ]
  ] [
fhir:code [ fhir:v "4.2" ] ;
fhir:display [ fhir:v "Study Reports (Nonclinical)" ]
  ] [
fhir:code [ fhir:v "5.1" ] ;
fhir:display [ fhir:v "Table of Contents (Clinical)" ]
  ] [
fhir:code [ fhir:v "5.2" ] ;
fhir:display [ fhir:v "Tabular Listing of All Clinical Studies" ]
  ] [
fhir:code [ fhir:v "5.3" ] ;
fhir:display [ fhir:v "Clinical Study Reports" ]
  ] [
fhir:code [ fhir:v "5.3.5" ] ;
fhir:display [ fhir:v "Reports of Efficacy and Safety Studies" ]
  ] [
fhir:code [ fhir:v "5.3.5.1" ] ;
fhir:display [ fhir:v "Study Reports of Controlled Clinical Studies" ]
  ] [
fhir:code [ fhir:v "5.3.5.3" ] ;
fhir:display [ fhir:v "Reports of Analysis of Data from More than One Study" ]
  ] ) . #