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