API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build International flag

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

ValueSet: APIX CTD/eCTD Section Code System

Official URL: http://hl7.org/fhir/uv/apix/ValueSet/apix-ctd-section-vs Version: 0.1.0
Standards status: Trial-use Maturity Level: 1 Computable Name: APIXCTDSectionVS

Value set for CTD section codes used in APIX regulatory submissions

References

Logical Definition (CLD)

This value set includes codes based on the following rules:

 

Expansion

Expansion performed internally based on codesystem APIX CTD/eCTD Section Code System v0.1.0 (CodeSystem)

This value set contains 47 concepts

SystemCodeDisplay (en)DefinitionJSONXML
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.0Cover LetterCover Letter
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.2Administrative InformationAdministrative Information
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.3.1SPC, Labelling and Package LeafletSPC, Labelling and Package Leaflet
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.3.2Mock-upsMock-ups
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.3.3SpecimensSpecimens
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.4Information about the ExpertsInformation about the Experts
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.8.1Risk Management PlanRisk Management Plan
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.9Pharmacovigilance SystemPharmacovigilance System
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.2IntroductionIntroduction
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.3Quality Overall SummaryQuality Overall Summary
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.4Nonclinical OverviewNonclinical Overview
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.5Clinical OverviewClinical Overview
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.6Nonclinical SummaryNonclinical Summary
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.7Clinical SummaryClinical Summary
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1General Information (Drug Substance)General Information (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1.1NomenclatureNomenclature
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1.2StructureStructure
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1.3General PropertiesGeneral Properties
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.2Manufacture (Drug Substance)Manufacture (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.3Characterisation (Drug Substance)Characterisation (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.4Control of Drug SubstanceControl of Drug Substance
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.5Reference Standards or MaterialsReference Standards or Materials
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.6Container Closure SystemContainer Closure System
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.7Stability (Drug Substance)Stability (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.1Description and Composition of the Drug ProductDescription and Composition of the Drug Product
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.2Pharmaceutical DevelopmentPharmaceutical Development
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.3Manufacture (Drug Product)Manufacture (Drug Product)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.4Control of ExcipientsControl of Excipients
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.5Control of Drug ProductControl of Drug Product
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.5.1Specification(s)Specification(s)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.5.6Justification of Specification(s)Justification of Specification(s)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8Stability (Drug Product)Stability (Drug Product)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8.1Stability Summary and ConclusionStability Summary and Conclusion
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8.2Post-approval Stability Protocol and CommitmentPost-approval Stability Protocol and Commitment
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8.3Stability DataStability Data
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.A.1Facilities and EquipmentFacilities and Equipment
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.A.2Adventitious Agents Safety EvaluationAdventitious Agents Safety Evaluation
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.A.3ExcipientsExcipients
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.RRegional InformationRegional Information
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  4.1Table of Contents (Nonclinical)Table of Contents (Nonclinical)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  4.2Study Reports (Nonclinical)Study Reports (Nonclinical)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.1Table of Contents (Clinical)Table of Contents (Clinical)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.2Tabular Listing of All Clinical StudiesTabular Listing of All Clinical Studies
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3Clinical Study ReportsClinical Study Reports
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3.5Reports of Efficacy and Safety StudiesReports of Efficacy and Safety Studies
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3.5.1Study Reports of Controlled Clinical StudiesStudy Reports of Controlled Clinical Studies
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3.5.3Reports of Analysis of Data from More than One StudyReports of Analysis of Data from More than One Study

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance)
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code