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
<QuestionnaireResponse xmlns="http://hl7.org/fhir">
<id value="RegulatoryQA-ID001-Response"/>
<meta>
<versionId value="1"/>
<lastUpdated value="2025-11-15T14:59:00-05:00"/>
<profile
value="http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse"/>
</meta>
<!-- Narrative -->
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml">
<h2>Response to Regulatory Questionnaire ID001</h2>
<p><b>Procedure:</b> EMEA/H/C/005432/II/0023</p>
<p><b>Product:</b> ExampleDrug 10 mg Tablets</p>
<p><b>Submitted by:</b> SynthPharma AG</p>
<p><b>Submitted to:</b> European Medicines Agency (EMA)</p>
<p><b>Date:</b> November 15, 2025</p>
<hr/>
<p>This response addresses all administrative, labeling, and CMC stability questions for the Type II Variation.</p>
</div>
</text>
<!-- Identifiers -->
<identifier>
<system value="http://hl7.org/fhir/uv/brr/identifier/qa-request"/>
<value value="ID001"/>
</identifier>
<identifier>
<system value="https://ema.europa.eu/procedure-number"/>
<value value="EMEA/H/C/005432/II/0023"/>
</identifier>
<!-- Reference to original Questionnaire -->
<questionnaire
value="http://hl7.org/fhir/uv/brr/Questionnaire/brr-regulatory-qa-questionnaire"/>
<status value="completed"/>
<subject>
<reference value="MedicinalProductDefinition/example-drug-10mg"/>
<display value="ExampleDrug 10 mg Tablets"/>
</subject>
<authored value="2025-11-15T14:59:00-05:00"/>
<!-- ====================== ANSWERS (exact match with Questionnaire) ====================== -->
<!-- admin-1 -->
<item>
<linkId value="admin-1"/>
<text
value="Is the fee for the Type II variation fully paid and documented?"/>
<answer>
<valueString
value="Yes, the fee was paid on June 25, 2025. Payment confirmation and receipt are included in the application form (see Section 1.1)."/>
</answer>
</item>
<!-- admin-2 -->
<item>
<linkId value="admin-2"/>
<text
value="Are all required metadata fields in the application form complete?"/>
<answer>
<valueString
value="Yes, all required metadata fields are complete: • MAH: SynthPharma AG • Product: ExampleDrug 10 mg Tablets • Procedure: EMEA/H/C/005432/II/0023 • Submission Date: 2025-06-25"/>
</answer>
</item>
<!-- labeling-1 -->
<item>
<linkId value="labeling-1"/>
<text
value="Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?"/>
<answer>
<valueString
value="No additional patient guidance is required. The ePI clearly states: 'Store in a refrigerator (2°C – 8°C). Do not freeze.' The 36-month shelf life is supported by stability data and does not alter patient handling instructions."/>
</answer>
</item>
<!-- labeling-2 -->
<item>
<linkId value="labeling-2"/>
<text
value="Is the patient leaflet revised to clarify the extended shelf life?"/>
<answer>
<valueString
value="Yes, the patient leaflet has been updated to state: 'Shelf life after first opening: 36 months when stored at 2–8°C'. The revised leaflet is included in the submission."/>
</answer>
</item>
<!-- labeling-3 -->
<item>
<linkId value="labeling-3"/>
<text
value="Is the updated ePI text sufficiently clear for all EU languages?"/>
<answer>
<valueString
value="Yes, the ePI text has been translated into all EU languages and reviewed for clarity. All versions are linguistically validated. Status: English (Approved), French (Approved), German (Approved), others (Final review completed)."/>
</answer>
</item>
<!-- cmc-1-DP-Stability -->
<item>
<linkId value="cmc-1-DP-Stability"/>
<text
value="Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?"/>
<answer>
<valueString
value="The submission includes both: • Additional timepoints: Long-term data extended to 36 months for primary batches A-001, A-002, A-003. • New stability studies: Two pilot-scale batches (B-001, B-002) in new Alu/Alu packaging, with 6-month accelerated (40°C/75% RH) and long-term (25°C/60% RH) data. No protocol deviations occurred. All studies follow ICH Q1A(R2)."/>
</answer>
</item>
<!-- cmc-2-DP-Stability -->
<item>
<linkId value="cmc-2-DP-Stability"/>
<text value="Does the data support all intended climatic zones?"/>
<answer>
<valueString
value="Yes, the data supports all ICH climatic zones, including Zone IVb: • Zone I/II: 25°C/60% RH (long-term), 40°C/75% RH (accelerated) • Zone IVb: 30°C/75% RH (long-term) — data confirms compliance per WHO TRS 1010. All batches remain within specification."/>
</answer>
</item>
<!-- cmc-3-DP-Analytical Methods -->
<item>
<linkId value="cmc-3-DP-Analytical Methods"/>
<text
value="Are the test methods used the same as in the previously submitted stability information?"/>
<answer>
<valueString
value="Yes, all test methods are identical to those validated in the original MAA. No changes were made. Methods remain stability-indicating for assay, impurities, and dissolution."/>
</answer>
</item>
<!-- cmc-4-DP-Impurities -->
<item>
<linkId value="cmc-4-DP-Impurities"/>
<text
value="Are there any new degradation products identified within the newly submitted data?"/>
<answer>
<valueString
value="No new degradation products were identified. All observed impurities correspond to previously qualified degradants. Levels remain below 0.10% (ICH Q3B(R2) threshold). No peaks above reporting threshold detected."/>
</answer>
</item>
<!-- cmc-5-DP-Container Closure System -->
<item>
<linkId value="cmc-5-DP-Container Closure System"/>
<text
value="Any changes in the packaging configuration and/or storage of the samples during stability?"/>
<answer>
<extension
url="http://hl7.org/fhir/uv/brr/StructureDefinition/questionnaire-itemRichText">
<valueXhtml/>
</extension>
<valueString
value="Yes, packaging changed from PVC/PVDC to Alu/Alu. New stability studies initiated. See rich text for diagram and details."/>
</answer>
</item>
</QuestionnaireResponse>