Response to Regulatory Questions (RTQ)
0.1.0 - ci-build

Response to Regulatory Questions (RTQ), published by HL7 International. 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/rtq-ig/ and changes regularly. See the Directory of published versions

: RTQ Questionnaire Type Code System - TTL Representation

Draft as of 2025-11-21

Raw ttl | Download


@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "rtq-questionnaire-type-cs"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem rtq-questionnaire-type-cs</b></p><a name=\"rtq-questionnaire-type-cs\"> </a><a name=\"hcrtq-questionnaire-type-cs\"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-questionnaire-type-cs</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">list-of-questions<a name=\"rtq-questionnaire-type-cs-list-of-questions\"> </a></td><td>List of Questions</td><td>A formal list of questions raised by a regulator requiring a written response from the marketing authorisation holder.</td></tr><tr><td style=\"white-space:nowrap\">list-of-issues<a name=\"rtq-questionnaire-type-cs-list-of-issues\"> </a></td><td>List of Issues</td><td>A consolidated list of major and minor issues identified during assessment that must be resolved before approval or variation.</td></tr><tr><td style=\"white-space:nowrap\">information-request<a name=\"rtq-questionnaire-type-cs-information-request\"> </a></td><td>Information Request</td><td>A formal request for additional information or clarification during evaluation of a submission (e.g., EMA Day 120/180 LoQ, FDA IR, Health Canada Clarifax).</td></tr><tr><td style=\"white-space:nowrap\">request-for-clarification<a name=\"rtq-questionnaire-type-cs-request-for-clarification\"> </a></td><td>Request for Clarification</td><td>Request seeking clarification on specific points in a submission (often used by PMDA, Health Canada, Swissmedic).</td></tr><tr><td style=\"white-space:nowrap\">request-for-supplementary-information<a name=\"rtq-questionnaire-type-cs-request-for-supplementary-information\"> </a></td><td>Request for Supplementary Information</td><td>Used by some regulators (e.g., Swissmedic RSI, Saudi SFDA) for additional data requests.</td></tr><tr><td style=\"white-space:nowrap\">deficiency-letter<a name=\"rtq-questionnaire-type-cs-deficiency-letter\"> </a></td><td>Deficiency Letter</td><td>Formal notification of deficiencies that must be addressed (common in some national procedures).</td></tr><tr><td style=\"white-space:nowrap\">consolidated-list-of-questions<a name=\"rtq-questionnaire-type-cs-consolidated-list-of-questions\"> </a></td><td>Consolidated List of Questions</td><td>A single consolidated set of questions from multiple assessment teams (e.g., EMA PRAC/RAPPS/CHMP consolidated LoQ).</td></tr></table></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:url [
fhir:v "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-questionnaire-type-cs"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-questionnaire-type-cs>
  ] ; # 
  fhir:version [ fhir:v "0.1.0"] ; # 
  fhir:name [ fhir:v "RtqQuestionnaireTypeCS"] ; # 
  fhir:title [ fhir:v "RTQ Questionnaire Type Code System"] ; # 
  fhir:status [ fhir:v "draft"] ; # 
  fhir:experimental [ fhir:v true] ; # 
  fhir:date [ fhir:v "2025-11-21"^^xsd:date] ; # 
  fhir:publisher [ fhir:v "HL7 International"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "HL7 International" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Code system defining the high-level types of regulatory questionnaires exchanged between industry and health authorities."] ; # 
  fhir:caseSensitive [ fhir:v true] ; # 
  fhir:content [ fhir:v "complete"] ; # 
  fhir:concept ( [
fhir:code [ fhir:v "list-of-questions" ] ;
fhir:display [ fhir:v "List of Questions" ] ;
fhir:definition [ fhir:v "A formal list of questions raised by a regulator requiring a written response from the marketing authorisation holder." ]
  ] [
fhir:code [ fhir:v "list-of-issues" ] ;
fhir:display [ fhir:v "List of Issues" ] ;
fhir:definition [ fhir:v "A consolidated list of major and minor issues identified during assessment that must be resolved before approval or variation." ]
  ] [
fhir:code [ fhir:v "information-request" ] ;
fhir:display [ fhir:v "Information Request" ] ;
fhir:definition [ fhir:v "A formal request for additional information or clarification during evaluation of a submission (e.g., EMA Day 120/180 LoQ, FDA IR, Health Canada Clarifax)." ]
  ] [
fhir:code [ fhir:v "request-for-clarification" ] ;
fhir:display [ fhir:v "Request for Clarification" ] ;
fhir:definition [ fhir:v "Request seeking clarification on specific points in a submission (often used by PMDA, Health Canada, Swissmedic)." ]
  ] [
fhir:code [ fhir:v "request-for-supplementary-information" ] ;
fhir:display [ fhir:v "Request for Supplementary Information" ] ;
fhir:definition [ fhir:v "Used by some regulators (e.g., Swissmedic RSI, Saudi SFDA) for additional data requests." ]
  ] [
fhir:code [ fhir:v "deficiency-letter" ] ;
fhir:display [ fhir:v "Deficiency Letter" ] ;
fhir:definition [ fhir:v "Formal notification of deficiencies that must be addressed (common in some national procedures)." ]
  ] [
fhir:code [ fhir:v "consolidated-list-of-questions" ] ;
fhir:display [ fhir:v "Consolidated List of Questions" ] ;
fhir:definition [ fhir:v "A single consolidated set of questions from multiple assessment teams (e.g., EMA PRAC/RAPPS/CHMP consolidated LoQ)." ]
  ] ) . #