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

Value Sets

RFICategoryAndSubcategory

  • URL: ValueSet-rfi-category-subcategory
  • Description: Categories and sub-categories for RFIs, aligned with ICH CTD.
  • Code Systems:
    • Categories: http://hl7.org/fhir/rfi-category
    • Sub-categories: http://hl7.org/fhir/rfi-subcategory
  • Categories:
    • Administrative
    • Labeling
    • CMC
    • Clinical
    • Non-clinical
  • Sub-categories (examples):
    • Administrative: ApplicationForm, AdministrativeDetails
    • Labeling: ProposedLabeling, RiskManagement
    • CMC: DrugSubstance, Stability
    • Clinical: Bioequivalence, ClinicalStudyReports
    • Non-clinical: Toxicology, Pharmacology

RFIPriority