API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
API for the Exchange of Medicinal Product Information (APIX), published by Gravitate Health Project. 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/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions
{
"resourceType" : "Task",
"id" : "task-nda-submission-index-2025",
"meta" : {
"versionId" : "1",
"lastUpdated" : "2025-12-20T14:15:00Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Task task-nda-submission-index-2025</b></p><a name=\"task-nda-submission-index-2025\"> </a><a name=\"hctask-nda-submission-index-2025\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 1; Last updated: 2025-12-20 14:15:00+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-apix-task.html\">APIX Regulatory Task</a></p></div><p><b>identifier</b>: Task Instance UUID/urn:uuid:8e4d2a-8b1c-4d9f-9a2e-nda-example\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: Requested</p><p><b>intent</b>: order</p><p><b>priority</b>: Routine</p><p><b>code</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-type new-drug-application}\">New Drug Application (NDA)</span></p><p><b>authoredOn</b>: 2025-12-20 14:15:00+0000</p><p><b>lastModified</b>: 2025-12-20 14:15:00+0000</p><p><b>requester</b>: <a href=\"#hctask-nda-submission-index-2025/org-synthpharma-ag\">Organization SynthPharma AG</a></p><p><b>owner</b>: <a href=\"#hctask-nda-submission-index-2025/org-ema\">Organization European Medicines Agency</a></p><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type regulatory-document}\">regulatory-document</span></p><p><b>value</b>: <a href=\"#hctask-nda-submission-index-2025/docref-m1-cover\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Cover Letter; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type regulatory-document}\">regulatory-document</span></p><p><b>value</b>: <a href=\"#hctask-nda-submission-index-2025/docref-m3-stability-data\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability; category = Module 3</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type regulatory-document}\">regulatory-document</span></p><p><b>value</b>: <a href=\"#hctask-nda-submission-index-2025/docref-m5-clinical-study\">DocumentReference: version = 1.0; status = current; docStatus = final; type = Reports of Efficacy and Safety Studies; category = Module 5</a></p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #org-synthpharma-ag</b></p><a name=\"task-nda-submission-index-2025/org-synthpharma-ag\"> </a><a name=\"hctask-nda-submission-index-2025/org-synthpharma-ag\"> </a><p><b>name</b>: SynthPharma AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #org-ema</b></p><a name=\"task-nda-submission-index-2025/org-ema\"> </a><a name=\"hctask-nda-submission-index-2025/org-ema\"> </a><p><b>name</b>: European Medicines Agency</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference #docref-m1-cover</b></p><a name=\"task-nda-submission-index-2025/docref-m1-cover\"> </a><a name=\"hctask-nda-submission-index-2025/docref-m1-cover\"> </a><p><b>version</b>: 1.0</p><p><b>status</b>: Current</p><p><b>docStatus</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.0}\">Cover Letter</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module m1}\">Module 1</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style=\"display: none\">*</td><td>application/pdf</td><td><a href=\"https://api.synthpharma.example/binaries/nda-12345/m1/cover-letter.pdf\">https://api.synthpharma.example/binaries/nda-12345/m1/cover-letter.pdf</a></td><td>1250000</td><td>Cover Letter.pdf</td><td>2025-12-20 14:00:00+0000</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference #docref-m3-stability-data</b></p><a name=\"task-nda-submission-index-2025/docref-m3-stability-data\"> </a><a name=\"hctask-nda-submission-index-2025/docref-m3-stability-data\"> </a><p><b>version</b>: 1.0</p><p><b>status</b>: Current</p><p><b>docStatus</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.P.8}\">Stability</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module m3}\">Module 3</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style=\"display: none\">*</td><td>application/zip</td><td><a href=\"https://api.synthpharma.example/binaries/nda-12345/m3/stability-package.zip\">https://api.synthpharma.example/binaries/nda-12345/m3/stability-package.zip</a></td><td>64424509440</td><td>Stability Data Package (60GB Referenced)</td><td>2025-12-15 10:00:00+0000</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: DocumentReference #docref-m5-clinical-study</b></p><a name=\"task-nda-submission-index-2025/docref-m5-clinical-study\"> </a><a name=\"hctask-nda-submission-index-2025/docref-m5-clinical-study\"> </a><p><b>version</b>: 1.0</p><p><b>status</b>: Current</p><p><b>docStatus</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 5.3.5}\">Reports of Efficacy and Safety Studies</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module m5}\">Module 5</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style=\"display: none\">*</td><td>application/pdf</td><td><a href=\"https://api.synthpharma.example/binaries/nda-12345/m5/study-report-001.pdf\">https://api.synthpharma.example/binaries/nda-12345/m5/study-report-001.pdf</a></td><td>45000000</td><td>Clinical Study Report - Phase III.pdf</td><td>2025-12-18 09:00:00+0000</td></tr></table></blockquote></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "org-synthpharma-ag",
"name" : "SynthPharma AG"
},
{
"resourceType" : "Organization",
"id" : "org-ema",
"name" : "European Medicines Agency"
},
{
"resourceType" : "DocumentReference",
"id" : "docref-m1-cover",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "1.0",
"display" : "Cover Letter"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module",
"code" : "m1",
"display" : "Module 1"
}
]
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/pdf",
"url" : "https://api.synthpharma.example/binaries/nda-12345/m1/cover-letter.pdf",
"size" : "1250000",
"title" : "Cover Letter.pdf",
"creation" : "2025-12-20T14:00:00Z"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "docref-m3-stability-data",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "3.2.P.8",
"display" : "Stability"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module",
"code" : "m3",
"display" : "Module 3"
}
]
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/zip",
"url" : "https://api.synthpharma.example/binaries/nda-12345/m3/stability-package.zip",
"size" : "64424509440",
"title" : "Stability Data Package (60GB Referenced)",
"creation" : "2025-12-15T10:00:00Z"
}
}
]
},
{
"resourceType" : "DocumentReference",
"id" : "docref-m5-clinical-study",
"version" : "1.0",
"status" : "current",
"docStatus" : "final",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section",
"code" : "5.3.5",
"display" : "Reports of Efficacy and Safety Studies"
}
]
},
"category" : [
{
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module",
"code" : "m5",
"display" : "Module 5"
}
]
}
],
"content" : [
{
"attachment" : {
"contentType" : "application/pdf",
"url" : "https://api.synthpharma.example/binaries/nda-12345/m5/study-report-001.pdf",
"size" : "45000000",
"title" : "Clinical Study Report - Phase III.pdf",
"creation" : "2025-12-18T09:00:00Z"
}
}
]
}
],
"identifier" : [
{
"use" : "official",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type",
"code" : "task-instance-uuid",
"display" : "Task Instance UUID"
}
]
},
"system" : "urn:ietf:rfc:3986",
"value" : "urn:uuid:8e4d2a-8b1c-4d9f-9a2e-nda-example"
}
],
"status" : "requested",
"intent" : "order",
"priority" : "routine",
"code" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-type",
"code" : "new-drug-application",
"display" : "New Drug Application (NDA)"
}
]
},
"authoredOn" : "2025-12-20T14:15:00Z",
"lastModified" : "2025-12-20T14:15:00Z",
"requester" : {
"reference" : "#org-synthpharma-ag"
},
"owner" : {
"reference" : "#org-ema"
},
"input" : [
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document"
}
]
},
"valueReference" : {
"reference" : "#docref-m1-cover"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document"
}
]
},
"valueReference" : {
"reference" : "#docref-m3-stability-data"
}
},
{
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type",
"code" : "regulatory-document"
}
]
},
"valueReference" : {
"reference" : "#docref-m5-clinical-study"
}
}
]
}