FHIR IG analytics
| Package | hl7.fhir.uv.rwi-pharma |
| Resource Type | CodeSystem |
| Id | CodeSystem-ctd-section.json |
| FHIR Version | R5 |
| Source | https://build.fhir.org/ig/HL7/reg-workflow-pharma/CodeSystem-ctd-section.html |
| URL | http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/ctd-section |
| Version | 0.1.0 |
| Status | active |
| Date | 2026-10-25T20:05:09+00:00 |
| Name | APIXCTDSECTION |
| Title | APIX CTD/eCTD Section Code System |
| Realm | uv |
| Authority | hl7 |
| 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 guidelines https://www.ich.org/page/ctd. |
| Content | complete |
Resources that use this resource
| ValueSet | ||
| hl7.fhir.uv.rwi-pharma#current | apix-ctd-module-vs | APIX CTD/eCTD Module Value Set |
Resources that this resource uses
No resources found
Narrative
Note: links and images are rebased to the (stated) source
Generated Narrative: CodeSystem ctd-section
This case-sensitive code system http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/ctd-section defines the following codes in a Is-A hierarchy:
Source1
{
"resourceType": "CodeSystem",
"id": "ctd-section",
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger": 1,
"_valueInteger": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/rwi-pharma/ImplementationGuide/hl7.fhir.uv.rwi-pharma"
}
]
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "trial-use",
"_valueCode": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
"valueCanonical": "http://hl7.org/fhir/uv/rwi-pharma/ImplementationGuide/hl7.fhir.uv.rwi-pharma"
}
]
}
}
],
"url": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/ctd-section",
"version": "0.1.0",
"name": "APIXCTDSECTION",
"title": "APIX CTD/eCTD Section Code System",
"status": "active",
"experimental": false,
"date": "2026-10-25T20:05:09+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"contact": [
{
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [
{
"system": "url",
"value": "http://www.hl7.org/Special/committees/rcrim"
}
]
}
],
"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 guidelines https://www.ich.org/page/ctd.",
"jurisdiction": [
{
"coding": [
{
"system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code": "001",
"display": "World"
}
]
}
],
"caseSensitive": true,
"hierarchyMeaning": "is-a",
"content": "complete",
"count": 63,
"concept": [
{
"code": "m1",
"display": "Module 1",
"definition": "Module 1: Administrative Information",
"concept": [
{
"code": "1.0",
"display": "Cover Letter",
"definition": "Cover Letter"
},
{
"code": "1.2",
"display": "Administrative Information",
"definition": "Administrative Information"
},
{
"code": "1.3.1",
"display": "SPC, Labelling and Package Leaflet",
"definition": "SPC, Labelling and Package Leaflet"
},
{
"code": "1.3.2",
"display": "Mock-ups",
"definition": "Mock-ups"
},
{
"code": "1.3.3",
"display": "Specimens",
"definition": "Specimens"
},
{
"code": "1.4",
"display": "Information about the Experts",
"definition": "Information about the Experts"
},
{
"code": "1.14.1.2",
"display": "Annotated draft labeling text",
"definition": "Annotated draft labeling text"
},
{
"code": "1.14.1.3",
"display": "Draft labeling text",
"definition": "Draft labeling text"
},
{
"code": "1.8.1",
"display": "Risk Management Plan",
"definition": "Risk Management Plan"
},
{
"code": "1.9",
"display": "Pharmacovigilance System",
"definition": "Pharmacovigilance System"
},
{
"code": "application-form",
"display": "Application Form",
"definition": "Application Form"
},
{
"code": "invoice-reg-fee",
"display": "Invoice Regulatory Fee",
"definition": "Invoice Regulatory Fee"
},
{
"code": "proof-Of-payment",
"display": "Proof of Payment",
"definition": "Proof of Payment"
},
{
"code": "acknowledgement-receipt",
"display": "Acknowledgement of Receipt",
"definition": "Acknowledgement of Receipt"
},
{
"code": "validation-report",
"display": "Validation Report",
"definition": "Validation Report"
},
{
"code": "list-of-questions",
"display": "List of Questions",
"definition": "List of Questions"
},
{
"code": "applicant-questionnaireResponse",
"display": "Applicant QuestionnaireResponse",
"definition": "Applicant QuestionnaireResponse"
},
{
"code": "approval-letter",
"display": "Approval Letter",
"definition": "Regulatory Approval Letter"
},
{
"code": "assessment-report",
"display": "Assessment Report",
"definition": "Regulatory Assessment Report"
}
]
},
{
"code": "m2",
"display": "Module 2",
"definition": "Module 2: Overviews and Summaries",
"concept": [
{
"code": "2.2",
"display": "Introduction",
"definition": "Introduction"
},
{
"code": "2.3",
"display": "Quality Overall Summary",
"definition": "Quality Overall Summary"
},
{
"code": "2.4",
"display": "Nonclinical Overview",
"definition": "Nonclinical Overview"
},
{
"code": "2.5",
"display": "Clinical Overview",
"definition": "Clinical Overview"
},
{
"code": "2.6",
"display": "Nonclinical Summary",
"definition": "Nonclinical Summary"
},
{
"code": "2.7",
"display": "Clinical Summary",
"definition": "Clinical Summary"
}
]
},
{
"code": "m3",
"display": "Module 3",
"definition": "Module 3: Quality (CMC)",
"concept": [
{
"code": "3.2.S.1",
"display": "General Information (Drug Substance)",
"definition": "General Information (Drug Substance)"
},
{
"code": "3.2.S.1.1",
"display": "Nomenclature",
"definition": "Nomenclature"
},
{
"code": "3.2.S.1.2",
"display": "Structure",
"definition": "Structure"
},
{
"code": "3.2.S.1.3",
"display": "General Properties",
"definition": "General Properties"
},
{
"code": "3.2.S.2",
"display": "Manufacture (Drug Substance)",
"definition": "Manufacture (Drug Substance)"
},
{
"code": "3.2.S.3",
"display": "Characterisation (Drug Substance)",
"definition": "Characterisation (Drug Substance)"
},
{
"code": "3.2.S.4",
"display": "Control of Drug Substance",
"definition": "Control of Drug Substance"
},
{
"code": "3.2.S.5",
"display": "Reference Standards or Materials",
"definition": "Reference Standards or Materials"
},
{
"code": "3.2.S.6",
"display": "Container Closure System",
"definition": "Container Closure System"
},
{
"code": "3.2.S.7",
"display": "Stability (Drug Substance)",
"definition": "Stability (Drug Substance)"
},
{
"code": "3.2.P.1",
"display": "Description and Composition of the Drug Product",
"definition": "Description and Composition of the Drug Product"
},
{
"code": "3.2.P.2",
"display": "Pharmaceutical Development",
"definition": "Pharmaceutical Development"
},
{
"code": "3.2.P.3",
"display": "Manufacture (Drug Product)",
"definition": "Manufacture (Drug Product)"
},
{
"code": "3.2.P.4",
"display": "Control of Excipients",
"definition": "Control of Excipients"
},
{
"code": "3.2.P.5",
"display": "Control of Drug Product",
"definition": "Control of Drug Product"
},
{
"code": "3.2.P.5.1",
"display": "Specification(s)",
"definition": "Specification(s)"
},
{
"code": "3.2.P.5.6",
"display": "Justification of Specification(s)",
"definition": "Justification of Specification(s)"
},
{
"code": "3.2.P.8",
"display": "Stability (Drug Product)",
"definition": "Stability (Drug Product)"
},
{
"code": "3.2.P.8.1",
"display": "Stability Summary and Conclusion",
"definition": "Stability Summary and Conclusion"
},
{
"code": "3.2.P.8.2",
"display": "Post-approval Stability Protocol and Commitment",
"definition": "Post-approval Stability Protocol and Commitment"
},
{
"code": "3.2.P.8.3",
"display": "Stability Data",
"definition": "Stability Data"
},
{
"code": "3.2.A.1",
"display": "Facilities and Equipment",
"definition": "Facilities and Equipment"
},
{
"code": "3.2.A.2",
"display": "Adventitious Agents Safety Evaluation",
"definition": "Adventitious Agents Safety Evaluation"
},
{
"code": "3.2.A.3",
"display": "Excipients",
"definition": "Excipients"
},
{
"code": "3.2.R",
"display": "Regional Information",
"definition": "Regional Information"
}
]
},
{
"code": "m4",
"display": "Module 4",
"definition": "Module 4: Nonclinical Study Reports",
"concept": [
{
"code": "4.1",
"display": "Table of Contents (Nonclinical)",
"definition": "Table of Contents (Nonclinical)"
},
{
"code": "4.2",
"display": "Study Reports (Nonclinical)",
"definition": "Study Reports (Nonclinical)"
}
]
},
{
"code": "m5",
"display": "Module 5",
"definition": "Module 5: Clinical Study Reports",
"concept": [
{
"code": "5.1",
"display": "Table of Contents (Clinical)",
"definition": "Table of Contents (Clinical)"
},
{
"code": "5.2",
"display": "Tabular Listing of All Clinical Studies",
"definition": "Tabular Listing of All Clinical Studies"
},
{
"code": "5.3",
"display": "Clinical Study Reports",
"definition": "Clinical Study Reports"
},
{
"code": "5.3.5",
"display": "Reports of Efficacy and Safety Studies",
"definition": "Reports of Efficacy and Safety Studies"
},
{
"code": "5.3.5.1",
"display": "Study Reports of Controlled Clinical Studies",
"definition": "Study Reports of Controlled Clinical Studies"
},
{
"code": "5.3.5.3",
"display": "Reports of Analysis of Data from More than One Study",
"definition": "Reports of Analysis of Data from More than One Study"
}
]
}
]
}
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