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
{
"resourceType" : "QuestionnaireResponse",
"id" : "RegulatoryQA-ID001-Response",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-11-15T14:59:00-05:00",
"profile" : [
🔗 "http://hl7.org/fhir/uv/brr/StructureDefinition/RegulatoryQuestionnaireResponse"
]
},
"text" : // Narrative
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <h2>Response to Regulatory Questionnaire ID001</h2>\n <p><b>Procedure:</b> EMEA/H/C/005432/II/0023</p>\n <p><b>Product:</b> ExampleDrug 10 mg Tablets</p>\n <p><b>Submitted by:</b> SynthPharma AG</p>\n <p><b>Submitted to:</b> European Medicines Agency (EMA)</p>\n <p><b>Date:</b> November 15, 2025</p>\n <hr/>\n <p>This response addresses all administrative, labeling, and CMC stability questions for the Type II Variation.</p>\n </div>"
},
"identifier" : [
// Identifiers
{
"system" : "http://hl7.org/fhir/uv/brr/identifier/qa-request",
"value" : "ID001"
},
{
"system" : "https://ema.europa.eu/procedure-number",
"value" : "EMEA/H/C/005432/II/0023"
}
],
"questionnaire" : "http://hl7.org/fhir/uv/brr/Questionnaire/brr-regulatory-qa-questionnaire",
"status" : "completed",
"subject" : // Reference to original Questionnaire
{
"reference" : "MedicinalProductDefinition/example-drug-10mg",
"display" : "ExampleDrug 10 mg Tablets"
},
"authored" : "2025-11-15T14:59:00-05:00",
"item" : [
// ====================== ANSWERS (exact match with Questionnaire) ======================
// admin-1
{
"linkId" : "admin-1",
"text" : "Is the fee for the Type II variation fully paid and documented?",
"answer" : [
{
"valueString" : "Yes, the fee was paid on June 25, 2025. Payment confirmation and receipt are included in the application form (see Section 1.1)."
}
]
},
{
"linkId" : "admin-2",
"text" : "Are all required metadata fields in the application form complete?",
"answer" : [
{
"valueString" : "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"
}
]
},
{
"linkId" : "labeling-1",
"text" : "Do the updated storage conditions (2–8°C for 36 months) require additional patient guidance?",
"answer" : [
{
"valueString" : "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."
}
]
},
{
"linkId" : "labeling-2",
"text" : "Is the patient leaflet revised to clarify the extended shelf life?",
"answer" : [
{
"valueString" : "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."
}
]
},
{
"linkId" : "labeling-3",
"text" : "Is the updated ePI text sufficiently clear for all EU languages?",
"answer" : [
{
"valueString" : "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)."
}
]
},
{
"linkId" : "cmc-1-DP-Stability",
"text" : "Are there any new stability studies conducted, or does the submission include only data from additional timepoints from previously submitted studies?",
"answer" : [
{
"valueString" : "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)."
}
]
},
{
"linkId" : "cmc-2-DP-Stability",
"text" : "Does the data support all intended climatic zones?",
"answer" : [
{
"valueString" : "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."
}
]
},
{
"linkId" : "cmc-3-DP-Analytical Methods",
"text" : "Are the test methods used the same as in the previously submitted stability information?",
"answer" : [
{
"valueString" : "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."
}
]
},
{
"linkId" : "cmc-4-DP-Impurities",
"text" : "Are there any new degradation products identified within the newly submitted data?",
"answer" : [
{
"valueString" : "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."
}
]
},
{
"linkId" : "cmc-5-DP-Container Closure System",
"text" : "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"
}
],
"valueString" : "Yes, packaging changed from PVC/PVDC to Alu/Alu. New stability studies initiated. See rich text for diagram and details."
}
]
}
]
}