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 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

CodeSystem: APIX CTD/eCTD Section Code System

Official URL: http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section Version: 0.1.0
Active as of 2025-11-24 Computable Name: APIX_CTD_Section

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.

This Code system is referenced in the content logical definition of the following value sets:

  • This CodeSystem is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

This case-sensitive code system http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section defines the following codes:

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