FHIR IG analytics| Package | hl7.fhir.uv.rtq-ig |
| Resource Type | QuestionnaireResponse |
| Id | QuestionnaireResponse-questionnaireresponse-ID001-round2.json |
| FHIR Version | R5 |
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Note: links and images are rebased to the (stated) source
Dear National Regulatory Authority,
Please find enclosed the responses of SynthPharma AG to the open questions in ID001-R2: the approved French and German ePI texts, and the identification and qualification of the N-oxide degradation product. In response to question quality-4.2, SynthPharma commits to a 13-week repeat-dose toxicity study, with the report due by 30 September 2026.
SynthPharma AG, Global Regulatory Strategy
FHIR
FHIRsmith{
"resourceType": "QuestionnaireResponse",
"id": "questionnaireresponse-ID001-round2",
"meta": {
"versionId": "1",
"lastUpdated": "2025-12-19T16:00:00Z",
"profile": [
"http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse"
]
},
"language": "en",
"text": {
"status": "additional",
"div": "<!-- snip (see above) -->"
},
"contained": [
{
"resourceType": "Organization",
"id": "org-mah",
"identifier": [
{
"system": "https://www.zefix.ch/en/SwissCompanyRegistry/UID",
"value": "CHE-123.456.789"
}
],
"name": "SynthPharma AG",
"contact": [
{
"telecom": [
{
"system": "email",
"value": "john.doe@synthpharma.ch"
}
],
"address": {
"text": "Industriestrasse 12, 4056 Basel, CH",
"line": [
"Industriestrasse 12"
],
"city": "Basel",
"postalCode": "4056",
"country": "CH"
}
}
]
}
],
"extension": [
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"url": "http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-response-version",
"valueString": "1.0"
},
{
"url": "http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-procedure-identifier",
"valueIdentifier": {
"system": "https://example-nra.example.org/procedure-number",
"value": "NRA/H/C/005432/II/0023"
}
}
],
"identifier": [
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type",
"code": "regulator-id",
"display": "Regulator-issued Identifier"
}
]
},
"system": "https://example-nra.example.org/question-set-id",
"value": "ID001-R2"
},
{
"type": {
"coding": [
{
"system": "http://hl7.org/fhir/uv/rtq/CodeSystem/rtq-identifier-type",
"code": "company-id",
"display": "Company-issued Identifier"
}
]
},
"system": "https://synthpharma.example/identifier/rtq-response",
"value": "SP-RTQ-2025-0163"
}
],
"questionnaire": "http://hl7.org/fhir/uv/rtq/Questionnaire/questionnaire-ID001-round2",
"status": "completed",
"subject": {
"reference": "MedicinalProductDefinition/MedicinalProduct-ExampleDrug",
"display": "ExampleDrug 10 mg Tablets"
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"authored": "2025-12-19T15:00:00+01:00",
"author": {
"reference": "#org-mah",
"type": "Organization",
"display": "SynthPharma AG"
},
"item": [
{
"linkId": "product-3",
"text": "Is the updated ePI text sufficiently clear for all applicable languages?",
"answer": [
{
"valueString": "Apologies for the omission. The approved French and German ePI texts (linguistic review completed 2025-12-12) are now included in the response package alongside the English text.",
"_valueString": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Apologies for the omission. The approved French and German ePI texts (linguistic review completed 2025-12-12) are now included in the response package alongside the English text.</p></div>"
}
]
}
}
]
},
{
"linkId": "quality-4",
"text": "Are there any new degradation products identified within the newly submitted data?",
"item": [
{
"linkId": "quality-4.1",
"text": "The chromatograms for batch B-002 at 6 months accelerated (40°C/75% RH) show an unidentified peak at RRT 0.85 at 0.12%, above the 0.10% identification threshold. Identify this degradation product and propose a specification limit.",
"answer": [
{
"valueString": "The peak at RRT 0.85 is the N-oxide of the active substance, identified by LC-MS and confirmed against a synthesized reference standard. It forms only under accelerated conditions in the Alu/Alu pack. Proposed shelf-life limit: NMT 0.15%.",
"_valueString": {
"extension": [
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"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The peak at RRT 0.85 is the N-oxide of the active substance, identified by LC-MS and confirmed against a synthesized reference standard. It forms only under accelerated conditions in the Alu/Alu pack. Proposed shelf-life limit: NMT 0.15%.</p></div>"
}
]
}
}
]
},
{
"extension": [
{
"extension": [
{
"url": "description",
"valueMarkdown": "Complete a 13-week repeat-dose toxicity study on the isolated N-oxide degradation product and submit the study report."
},
{
"url": "dueDate",
"valueDate": "2026-09-30"
}
],
"url": "http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-commitment"
}
],
"linkId": "quality-4.2",
"text": "Provide the toxicological qualification of this degradation product per ICH Q3B(R2), or justify why qualification is not required.",
"answer": [
{
"valueString": "The N-oxide is a major human metabolite, so it is qualified at the proposed limit of 0.15% per ICH Q3B(R2). To confirm this, SynthPharma commits to a 13-week repeat-dose toxicity study on the isolated N-oxide.",
"_valueString": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/rendering-xhtml",
"valueString": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The N-oxide is a major human metabolite, so it is qualified at the proposed limit of 0.15% per ICH Q3B(R2). To confirm this, SynthPharma commits to a 13-week repeat-dose toxicity study on the isolated N-oxide.</p></div>"
}
]
}
}
]
}
]
}
]
}