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 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
| 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
Expansion performed internally based on codesystem APIX CTD/eCTD Section Code System v0.1.0 (CodeSystem)
This value set contains 47 concepts
| System | Code | Display (en) | JSON | XML |
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 1.0 | Cover Letter | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 1.2 | Administrative Information | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 1.3.1 | SPC, Labelling and Package Leaflet | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 1.3.2 | Mock-ups | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 1.3.3 | Specimens | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 1.4 | Information about the Experts | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 1.8.1 | Risk Management Plan | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 1.9 | Pharmacovigilance System | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 2.2 | Introduction | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 2.3 | Quality Overall Summary | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 2.4 | Nonclinical Overview | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 2.5 | Clinical Overview | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 2.6 | Nonclinical Summary | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 2.7 | Clinical Summary | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.S.1 | General Information (Drug Substance) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.S.1.1 | Nomenclature | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.S.1.2 | Structure | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.S.1.3 | General Properties | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.S.2 | Manufacture (Drug Substance) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.S.3 | Characterisation (Drug Substance) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.S.4 | Control of Drug Substance | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.S.5 | Reference Standards or Materials | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.S.6 | Container Closure System | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.S.7 | Stability (Drug Substance) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.1 | Description and Composition of the Drug Product | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.2 | Pharmaceutical Development | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.3 | Manufacture (Drug Product) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.4 | Control of Excipients | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.5 | Control of Drug Product | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.5.1 | Specification(s) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.5.6 | Justification of Specification(s) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.8 | Stability (Drug Product) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.8.1 | Stability Summary and Conclusion | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.8.2 | Post-approval Stability Protocol and Commitment | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.P.8.3 | Stability Data | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.A.1 | Facilities and Equipment | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.A.2 | Adventitious Agents Safety Evaluation | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.A.3 | Excipients | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 3.2.R | Regional Information | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 4.1 | Table of Contents (Nonclinical) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 4.2 | Study Reports (Nonclinical) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 5.1 | Table of Contents (Clinical) | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 5.2 | Tabular Listing of All Clinical Studies | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 5.3 | Clinical Study Reports | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 5.3.5 | Reports of Efficacy and Safety Studies | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 5.3.5.1 | Study Reports of Controlled Clinical Studies | ||
http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section | 5.3.5.3 | Reports 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 |