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
| Draft as of 2025-11-21 |
{
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"id" : "rtq-questionnaire-type-cs",
"text" : {
"status" : "generated",
"div" : "<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>"
},
"url" : "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-questionnaire-type-cs",
"version" : "0.1.0",
"name" : "RtqQuestionnaireTypeCS",
"title" : "RTQ Questionnaire Type Code System",
"status" : "draft",
"experimental" : true,
"date" : "2025-11-21",
"publisher" : "HL7 International",
"contact" : [
{
"name" : "HL7 International",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org"
}
]
}
],
"description" : "Code system defining the high-level types of regulatory questionnaires exchanged between industry and health authorities.",
"caseSensitive" : true,
"content" : "complete",
"concept" : [
{
"code" : "list-of-questions",
"display" : "List of Questions",
"definition" : "A formal list of questions raised by a regulator requiring a written response from the marketing authorisation holder."
},
{
"code" : "list-of-issues",
"display" : "List of Issues",
"definition" : "A consolidated list of major and minor issues identified during assessment that must be resolved before approval or variation."
},
{
"code" : "information-request",
"display" : "Information Request",
"definition" : "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)."
},
{
"code" : "request-for-clarification",
"display" : "Request for Clarification",
"definition" : "Request seeking clarification on specific points in a submission (often used by PMDA, Health Canada, Swissmedic)."
},
{
"code" : "request-for-supplementary-information",
"display" : "Request for Supplementary Information",
"definition" : "Used by some regulators (e.g., Swissmedic RSI, Saudi SFDA) for additional data requests."
},
{
"code" : "deficiency-letter",
"display" : "Deficiency Letter",
"definition" : "Formal notification of deficiencies that must be addressed (common in some national procedures)."
},
{
"code" : "consolidated-list-of-questions",
"display" : "Consolidated List of Questions",
"definition" : "A single consolidated set of questions from multiple assessment teams (e.g., EMA PRAC/RAPPS/CHMP consolidated LoQ)."
}
]
}