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 guidelines https://www.ich.org/page/ctd.

This Code system is referenced in the 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   1.14.1.2 Annotated draft labeling text Annotated draft labeling text
2   1.14.1.3 Draft labeling text Draft labeling text
2   1.8.1 Risk Management Plan Risk Management Plan
2   1.9 Pharmacovigilance System Pharmacovigilance System
2   application-form Application Form Application Form
2   invoice-reg-fee Invoice Regulatory Fee Invoice Regulatory Fee
2   proof-Of-payment Proof of Payment Proof of Payment
2   acknowledgement-receipt Acknowledgement of Receipt Acknowledgement of Receipt
2   validation-report Validation Report Validation Report
2   list-of-questions List of Questions List of Questions
2   applicant-questionnaireResponse" Applicant QuestionnaireResponse Applicant QuestionnaireResponse
2   approval-letter Approval Letter Regulatory Approval Letter
2   assessment-report Assessment Report Regulatory Assessment Report
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

Description of the above table(s).