API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
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 HL7 International / Biomedical Research and Regulation. 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
| Page standards status: Trial-use | Maturity Level: 1 |
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"div" : "<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 in a Is-A hierarchy:</p><table class=\"codes\"><tr><td><b>Lvl</b></td><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td>1</td><td style=\"white-space:nowrap\">m1<a name=\"ctd-section-m1\"> </a></td><td>Module 1</td><td>Module 1: Administrative Information</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a01.0<a name=\"ctd-section-1.460\"> </a></td><td>Cover Letter</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a01.2<a name=\"ctd-section-1.462\"> </a></td><td>Administrative Information</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a01.3.1<a name=\"ctd-section-1.463.461\"> </a></td><td>SPC, Labelling and Package Leaflet</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a01.3.2<a name=\"ctd-section-1.463.462\"> </a></td><td>Mock-ups</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a01.3.3<a name=\"ctd-section-1.463.463\"> </a></td><td>Specimens</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a01.4<a name=\"ctd-section-1.464\"> </a></td><td>Information about the Experts</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a01.8.1<a name=\"ctd-section-1.468.461\"> </a></td><td>Risk Management Plan</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a01.9<a name=\"ctd-section-1.469\"> </a></td><td>Pharmacovigilance System</td><td/></tr><tr><td>1</td><td style=\"white-space:nowrap\">m2<a name=\"ctd-section-m2\"> </a></td><td>Module 2</td><td>Module 2: Overviews and Summaries</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a02.2<a name=\"ctd-section-2.462\"> </a></td><td>Introduction</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a02.3<a name=\"ctd-section-2.463\"> </a></td><td>Quality Overall Summary</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a02.4<a name=\"ctd-section-2.464\"> </a></td><td>Nonclinical Overview</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a02.5<a name=\"ctd-section-2.465\"> </a></td><td>Clinical Overview</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a02.6<a name=\"ctd-section-2.466\"> </a></td><td>Nonclinical Summary</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a02.7<a name=\"ctd-section-2.467\"> </a></td><td>Clinical Summary</td><td/></tr><tr><td>1</td><td style=\"white-space:nowrap\">m3<a name=\"ctd-section-m3\"> </a></td><td>Module 3</td><td>Module 3: Quality (CMC)</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.S.1<a name=\"ctd-section-3.462.46S.461\"> </a></td><td>General Information (Drug Substance)</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.S.1.1<a name=\"ctd-section-3.462.46S.461.461\"> </a></td><td>Nomenclature</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.S.1.2<a name=\"ctd-section-3.462.46S.461.462\"> </a></td><td>Structure</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.S.1.3<a name=\"ctd-section-3.462.46S.461.463\"> </a></td><td>General Properties</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.S.2<a name=\"ctd-section-3.462.46S.462\"> </a></td><td>Manufacture (Drug Substance)</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.S.3<a name=\"ctd-section-3.462.46S.463\"> </a></td><td>Characterisation (Drug Substance)</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.S.4<a name=\"ctd-section-3.462.46S.464\"> </a></td><td>Control of Drug Substance</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.S.5<a name=\"ctd-section-3.462.46S.465\"> </a></td><td>Reference Standards or Materials</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.S.6<a name=\"ctd-section-3.462.46S.466\"> </a></td><td>Container Closure System</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.S.7<a name=\"ctd-section-3.462.46S.467\"> </a></td><td>Stability (Drug Substance)</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.1<a name=\"ctd-section-3.462.46P.461\"> </a></td><td>Description and Composition of the Drug Product</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.2<a name=\"ctd-section-3.462.46P.462\"> </a></td><td>Pharmaceutical Development</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.3<a name=\"ctd-section-3.462.46P.463\"> </a></td><td>Manufacture (Drug Product)</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.4<a name=\"ctd-section-3.462.46P.464\"> </a></td><td>Control of Excipients</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.5<a name=\"ctd-section-3.462.46P.465\"> </a></td><td>Control of Drug Product</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.5.1<a name=\"ctd-section-3.462.46P.465.461\"> </a></td><td>Specification(s)</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.5.6<a name=\"ctd-section-3.462.46P.465.466\"> </a></td><td>Justification of Specification(s)</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.8<a name=\"ctd-section-3.462.46P.468\"> </a></td><td>Stability (Drug Product)</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.8.1<a name=\"ctd-section-3.462.46P.468.461\"> </a></td><td>Stability Summary and Conclusion</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.8.2<a name=\"ctd-section-3.462.46P.468.462\"> </a></td><td>Post-approval Stability Protocol and Commitment</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.P.8.3<a name=\"ctd-section-3.462.46P.468.463\"> </a></td><td>Stability Data</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.A.1<a name=\"ctd-section-3.462.46A.461\"> </a></td><td>Facilities and Equipment</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.A.2<a name=\"ctd-section-3.462.46A.462\"> </a></td><td>Adventitious Agents Safety Evaluation</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.A.3<a name=\"ctd-section-3.462.46A.463\"> </a></td><td>Excipients</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a03.2.R<a name=\"ctd-section-3.462.46R\"> </a></td><td>Regional Information</td><td/></tr><tr><td>1</td><td style=\"white-space:nowrap\">m4<a name=\"ctd-section-m4\"> </a></td><td>Module 4</td><td>Module 4: Nonclinical Study Reports</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a04.1<a name=\"ctd-section-4.461\"> </a></td><td>Table of Contents (Nonclinical)</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a04.2<a name=\"ctd-section-4.462\"> </a></td><td>Study Reports (Nonclinical)</td><td/></tr><tr><td>1</td><td style=\"white-space:nowrap\">m5<a name=\"ctd-section-m5\"> </a></td><td>Module 5</td><td>Module 5: Clinical Study Reports</td></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a05.1<a name=\"ctd-section-5.461\"> </a></td><td>Table of Contents (Clinical)</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a05.2<a name=\"ctd-section-5.462\"> </a></td><td>Tabular Listing of All Clinical Studies</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a05.3<a name=\"ctd-section-5.463\"> </a></td><td>Clinical Study Reports</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a05.3.5<a name=\"ctd-section-5.463.465\"> </a></td><td>Reports of Efficacy and Safety Studies</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a05.3.5.1<a name=\"ctd-section-5.463.465.461\"> </a></td><td>Study Reports of Controlled Clinical Studies</td><td/></tr><tr><td>2</td><td style=\"white-space:nowrap\">\u00a0\u00a05.3.5.3<a name=\"ctd-section-5.463.465.463\"> </a></td><td>Reports of Analysis of Data from More than One Study</td><td/></tr></table></div>"
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"extension" : [
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"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
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],
"url" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"version" : "0.1.0",
"name" : "APIXCTDSECTION",
"title" : "APIX CTD/eCTD Section Code System",
"status" : "active",
"experimental" : false,
"date" : "2026-02-24T20:04:21+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International / Biomedical Research and Regulation",
"telecom" : [
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"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
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"description" : "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.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
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}
],
"caseSensitive" : true,
"hierarchyMeaning" : "is-a",
"content" : "complete",
"count" : 52,
"concept" : [
{
"code" : "m1",
"display" : "Module 1",
"definition" : "Module 1: Administrative Information",
"concept" : [
{
"code" : "1.0",
"display" : "Cover Letter"
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{
"code" : "1.2",
"display" : "Administrative Information"
},
{
"code" : "1.3.1",
"display" : "SPC, Labelling and Package Leaflet"
},
{
"code" : "1.3.2",
"display" : "Mock-ups"
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{
"code" : "1.3.3",
"display" : "Specimens"
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{
"code" : "1.4",
"display" : "Information about the Experts"
},
{
"code" : "1.8.1",
"display" : "Risk Management Plan"
},
{
"code" : "1.9",
"display" : "Pharmacovigilance System"
}
]
},
{
"code" : "m2",
"display" : "Module 2",
"definition" : "Module 2: Overviews and Summaries",
"concept" : [
{
"code" : "2.2",
"display" : "Introduction"
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{
"code" : "2.3",
"display" : "Quality Overall Summary"
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{
"code" : "2.4",
"display" : "Nonclinical Overview"
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{
"code" : "2.5",
"display" : "Clinical Overview"
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{
"code" : "2.6",
"display" : "Nonclinical Summary"
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{
"code" : "2.7",
"display" : "Clinical Summary"
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]
},
{
"code" : "m3",
"display" : "Module 3",
"definition" : "Module 3: Quality (CMC)",
"concept" : [
{
"code" : "3.2.S.1",
"display" : "General Information (Drug Substance)"
},
{
"code" : "3.2.S.1.1",
"display" : "Nomenclature"
},
{
"code" : "3.2.S.1.2",
"display" : "Structure"
},
{
"code" : "3.2.S.1.3",
"display" : "General Properties"
},
{
"code" : "3.2.S.2",
"display" : "Manufacture (Drug Substance)"
},
{
"code" : "3.2.S.3",
"display" : "Characterisation (Drug Substance)"
},
{
"code" : "3.2.S.4",
"display" : "Control of Drug Substance"
},
{
"code" : "3.2.S.5",
"display" : "Reference Standards or Materials"
},
{
"code" : "3.2.S.6",
"display" : "Container Closure System"
},
{
"code" : "3.2.S.7",
"display" : "Stability (Drug Substance)"
},
{
"code" : "3.2.P.1",
"display" : "Description and Composition of the Drug Product"
},
{
"code" : "3.2.P.2",
"display" : "Pharmaceutical Development"
},
{
"code" : "3.2.P.3",
"display" : "Manufacture (Drug Product)"
},
{
"code" : "3.2.P.4",
"display" : "Control of Excipients"
},
{
"code" : "3.2.P.5",
"display" : "Control of Drug Product"
},
{
"code" : "3.2.P.5.1",
"display" : "Specification(s)"
},
{
"code" : "3.2.P.5.6",
"display" : "Justification of Specification(s)"
},
{
"code" : "3.2.P.8",
"display" : "Stability (Drug Product)"
},
{
"code" : "3.2.P.8.1",
"display" : "Stability Summary and Conclusion"
},
{
"code" : "3.2.P.8.2",
"display" : "Post-approval Stability Protocol and Commitment"
},
{
"code" : "3.2.P.8.3",
"display" : "Stability Data"
},
{
"code" : "3.2.A.1",
"display" : "Facilities and Equipment"
},
{
"code" : "3.2.A.2",
"display" : "Adventitious Agents Safety Evaluation"
},
{
"code" : "3.2.A.3",
"display" : "Excipients"
},
{
"code" : "3.2.R",
"display" : "Regional Information"
}
]
},
{
"code" : "m4",
"display" : "Module 4",
"definition" : "Module 4: Nonclinical Study Reports",
"concept" : [
{
"code" : "4.1",
"display" : "Table of Contents (Nonclinical)"
},
{
"code" : "4.2",
"display" : "Study Reports (Nonclinical)"
}
]
},
{
"code" : "m5",
"display" : "Module 5",
"definition" : "Module 5: Clinical Study Reports",
"concept" : [
{
"code" : "5.1",
"display" : "Table of Contents (Clinical)"
},
{
"code" : "5.2",
"display" : "Tabular Listing of All Clinical Studies"
},
{
"code" : "5.3",
"display" : "Clinical Study Reports"
},
{
"code" : "5.3.5",
"display" : "Reports of Efficacy and Safety Studies"
},
{
"code" : "5.3.5.1",
"display" : "Study Reports of Controlled Clinical Studies"
},
{
"code" : "5.3.5.3",
"display" : "Reports of Analysis of Data from More than One Study"
}
]
}
]
}