Regulatory Correspondence
0.1.0 - ci-build

Regulatory Correspondence, published by Gravitate Health and HL7 Vulcan. 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/cander2/rfi-ig/ and changes regularly. See the Directory of published versions

ValueSet: RFICategoryAndSubcategory

Official URL: http://hl7.org/fhir/ValueSet/rfi-category-subcategory Version: 0.1.0
Draft as of 2025-06-19 Computable Name: RFICategoryAndSubcategory

Categories and sub-categories for RFI questions, aligned to ICH CTD headings.

References

Logical Definition (CLD)

This value set includes codes based on the following rules:

  • Include these codes as defined in http://hl7.org/fhir/rfi-category
    CodeDisplay
    AdministrativeAdministrative
    LabelingLabeling
    CMCCMC
    ClinicalClinical
    Non-clinicalNon-clinical
  • Include these codes as defined in http://hl7.org/fhir/rfi-subcategory
    CodeDisplay
    ApplicationForm Application Form
    AdministrativeDetails Administrative Details
    ProposedLabeling Proposed Labeling
    RiskManagement Risk Management
    DrugSubstance Drug Substance
    Stability Stability
    Bioequivalence Bioequivalence
    ClinicalStudyReports Clinical Study Reports
    Toxicology Toxicology
    Pharmacology Pharmacology

 

Expansion

No Expansion for this valueset (Unknown Code System)

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