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

CodeSystem: APIX CTD/eCTD Section Code System

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

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 case-sensitive code system http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section defines the following codes in a Is-A hierarchy:

LvlCodeDisplayDefinition
1 m1 Module 1 Module 1: Administrative Information
2   1.0 Cover Letter Cover Letter
2   1.2 Administrative Information Administrative Information
2   1.3.1 SPC, Labelling and Package Leaflet SPC, Labelling and Package Leaflet
2   1.3.2 Mock-ups Mock-ups
2   1.3.3 Specimens Specimens
2   1.4 Information about the Experts Information about the Experts
2   1.8.1 Risk Management Plan Risk Management Plan
2   1.9 Pharmacovigilance System Pharmacovigilance System
1 m2 Module 2 Module 2: Overviews and Summaries
2   2.2 Introduction Introduction
2   2.3 Quality Overall Summary Quality Overall Summary
2   2.4 Nonclinical Overview Nonclinical Overview
2   2.5 Clinical Overview Clinical Overview
2   2.6 Nonclinical Summary Nonclinical Summary
2   2.7 Clinical Summary Clinical Summary
1 m3 Module 3 Module 3: Quality (CMC)
2   3.2.S.1 General Information (Drug Substance) General Information (Drug Substance)
2   3.2.S.1.1 Nomenclature Nomenclature
2   3.2.S.1.2 Structure Structure
2   3.2.S.1.3 General Properties General Properties
2   3.2.S.2 Manufacture (Drug Substance) Manufacture (Drug Substance)
2   3.2.S.3 Characterisation (Drug Substance) Characterisation (Drug Substance)
2   3.2.S.4 Control of Drug Substance Control of Drug Substance
2   3.2.S.5 Reference Standards or Materials Reference Standards or Materials
2   3.2.S.6 Container Closure System Container Closure System
2   3.2.S.7 Stability (Drug Substance) Stability (Drug Substance)
2   3.2.P.1 Description and Composition of the Drug Product Description and Composition of the Drug Product
2   3.2.P.2 Pharmaceutical Development Pharmaceutical Development
2   3.2.P.3 Manufacture (Drug Product) Manufacture (Drug Product)
2   3.2.P.4 Control of Excipients Control of Excipients
2   3.2.P.5 Control of Drug Product Control of Drug Product
2   3.2.P.5.1 Specification(s) Specification(s)
2   3.2.P.5.6 Justification of Specification(s) Justification of Specification(s)
2   3.2.P.8 Stability (Drug Product) Stability (Drug Product)
2   3.2.P.8.1 Stability Summary and Conclusion Stability Summary and Conclusion
2   3.2.P.8.2 Post-approval Stability Protocol and Commitment Post-approval Stability Protocol and Commitment
2   3.2.P.8.3 Stability Data Stability Data
2   3.2.A.1 Facilities and Equipment Facilities and Equipment
2   3.2.A.2 Adventitious Agents Safety Evaluation Adventitious Agents Safety Evaluation
2   3.2.A.3 Excipients Excipients
2   3.2.R Regional Information Regional Information
1 m4 Module 4 Module 4: Nonclinical Study Reports
2   4.1 Table of Contents (Nonclinical) Table of Contents (Nonclinical)
2   4.2 Study Reports (Nonclinical) Study Reports (Nonclinical)
1 m5 Module 5 Module 5: Clinical Study Reports
2   5.1 Table of Contents (Clinical) Table of Contents (Clinical)
2   5.2 Tabular Listing of All Clinical Studies Tabular Listing of All Clinical Studies
2   5.3 Clinical Study Reports Clinical Study Reports
2   5.3.5 Reports of Efficacy and Safety Studies Reports of Efficacy and Safety Studies
2   5.3.5.1 Study Reports of Controlled Clinical Studies Study Reports of Controlled Clinical Studies
2   5.3.5.3 Reports of Analysis of Data from More than One Study Reports of Analysis of Data from More than One Study