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)

 

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)JSONXML
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.0Cover Letter
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.2Administrative Information
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.3.1SPC, Labelling and Package Leaflet
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.3.2Mock-ups
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.3.3Specimens
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.4Information about the Experts
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.8.1Risk Management Plan
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  1.9Pharmacovigilance System
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.2Introduction
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.3Quality Overall Summary
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.4Nonclinical Overview
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.5Clinical Overview
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.6Nonclinical Summary
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  2.7Clinical Summary
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1General Information (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1.1Nomenclature
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1.2Structure
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.1.3General Properties
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.2Manufacture (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.3Characterisation (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.4Control of Drug Substance
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.5Reference Standards or Materials
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.6Container Closure System
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.S.7Stability (Drug Substance)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.1Description and Composition of the Drug Product
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.2Pharmaceutical Development
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.3Manufacture (Drug Product)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.4Control of Excipients
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.5Control of Drug Product
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.5.1Specification(s)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.5.6Justification of Specification(s)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8Stability (Drug Product)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8.1Stability Summary and Conclusion
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8.2Post-approval Stability Protocol and Commitment
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.P.8.3Stability Data
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.A.1Facilities and Equipment
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.A.2Adventitious Agents Safety Evaluation
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.A.3Excipients
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  3.2.RRegional Information
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  4.1Table of Contents (Nonclinical)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  4.2Study Reports (Nonclinical)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.1Table of Contents (Clinical)
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.2Tabular Listing of All Clinical Studies
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3Clinical Study Reports
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3.5Reports of Efficacy and Safety Studies
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section  5.3.5.1Study 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 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