Regulatory Workflows and Interactions - pharma
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Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. 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

: APIX Regulatory Business Status

Page standards status: Trial-use Maturity Level: 1

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

<http://hl7.org/fhir/CodeSystem/apix-business-status> a fhir:CodeSystem ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "apix-business-status"] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
     fhir:status [ fhir:v "generated" ] ;
     fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem apix-business-status</b></p><a name=\"apix-business-status\"> </a><a name=\"hcapix-business-status\"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status</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\">submitted<a name=\"apix-business-status-submitted\"> </a></td><td>Submitted</td><td>The application has been submitted by the applicant.</td></tr><tr><td style=\"white-space:nowrap\">received<a name=\"apix-business-status-received\"> </a></td><td>Received</td><td>The application or submission has been received by the regulator.</td></tr><tr><td style=\"white-space:nowrap\">validation-successful<a name=\"apix-business-status-validation-successful\"> </a></td><td>Validation Successful</td><td>The technical and administrative validation has been completed successfully.</td></tr><tr><td style=\"white-space:nowrap\">validation-failed<a name=\"apix-business-status-validation-failed\"> </a></td><td>Validation Failed</td><td>The submission failed validation and cannot proceed.</td></tr><tr><td style=\"white-space:nowrap\">under-assessment<a name=\"apix-business-status-under-assessment\"> </a></td><td>Under Assessment</td><td>The submission is currently undergoing scientific review.</td></tr><tr><td style=\"white-space:nowrap\">clock-stop<a name=\"apix-business-status-clock-stop\"> </a></td><td>Clock Stop</td><td>The review timeline is paused, typically waiting for applicant response to questions.</td></tr><tr><td style=\"white-space:nowrap\">clock-restart<a name=\"apix-business-status-clock-restart\"> </a></td><td>Clock Restart</td><td>The review timeline has resumed following receipt of a response.</td></tr><tr><td style=\"white-space:nowrap\">consolidated-review<a name=\"apix-business-status-consolidated-review\"> </a></td><td>Consolidated Review</td><td>Comments from multiple assessors are being consolidated.</td></tr><tr><td style=\"white-space:nowrap\">decision-pending<a name=\"apix-business-status-decision-pending\"> </a></td><td>Decision Pending</td><td>The assessment is complete and the final decision is being prepared.</td></tr><tr><td style=\"white-space:nowrap\">approved<a name=\"apix-business-status-approved\"> </a></td><td>Approved</td><td>The application has been approved.</td></tr><tr><td style=\"white-space:nowrap\">rejected<a name=\"apix-business-status-rejected\"> </a></td><td>Rejected</td><td>The application has been rejected.</td></tr><tr><td style=\"white-space:nowrap\">withdrawn<a name=\"apix-business-status-withdrawn\"> </a></td><td>Withdrawn</td><td>The application has been withdrawn by the applicant.</td></tr><tr><td style=\"white-space:nowrap\">payment-requested<a name=\"apix-business-status-payment-requested\"> </a></td><td>Payment Requested</td><td>A fee payment has been requested by the regulator.</td></tr><tr><td style=\"white-space:nowrap\">payment-received<a name=\"apix-business-status-payment-received\"> </a></td><td>Payment Received</td><td>The fee payment has been received and confirmed.</td></tr><tr><td style=\"white-space:nowrap\">icsr-accepted<a name=\"apix-business-status-icsr-accepted\"> </a></td><td>Report Accepted (CA)</td><td>The individual report was accepted. ICH E2B(R3) report acknowledgment code CA (ACK.B.r.6).</td></tr><tr><td style=\"white-space:nowrap\">request-for-information-issued<a name=\"apix-business-status-request-for-information-issued\"> </a></td><td>Request for Information Issued</td><td>The regulator has sent a request for information to the sponsor.</td></tr><tr><td style=\"white-space:nowrap\">authorised<a name=\"apix-business-status-authorised\"> </a></td><td>Authorised</td><td>The trial or modification has been authorised.</td></tr><tr><td style=\"white-space:nowrap\">labelling-comments-issued<a name=\"apix-business-status-labelling-comments-issued\"> </a></td><td>Labelling Comments Issued</td><td>The regulator has returned comments or a revised version to the applicant.</td></tr><tr><td style=\"white-space:nowrap\">counter-proposal-received<a name=\"apix-business-status-counter-proposal-received\"> </a></td><td>Counter-Proposal Received</td><td>The applicant has returned a counter-proposal on the product information.</td></tr><tr><td style=\"white-space:nowrap\">response-received<a name=\"apix-business-status-response-received\"> </a></td><td>Response Received</td><td>The applicant’s response has been received.</td></tr><tr><td style=\"white-space:nowrap\">awaiting-applicant-response<a name=\"apix-business-status-awaiting-applicant-response\"> </a></td><td>Awaiting Applicant Response</td><td>The regulator is waiting for the applicant to respond.</td></tr><tr><td style=\"white-space:nowrap\">labelling-agreed<a name=\"apix-business-status-labelling-agreed\"> </a></td><td>Labelling Agreed</td><td>Applicant and regulator have agreed the product information text.</td></tr></table></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
     fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
     fhir:value [
       a fhir:code ;
       fhir:v "brr"
     ]
  ] [
     fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ;
     fhir:value [
       a fhir:integer ;
       fhir:v 1 ;
       fhir:extension ( [
         fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
         fhir:value [
           a fhir:canonical ;
           fhir:v "http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"^^xsd:anyURI ;
           fhir:link <http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix>
         ]
       ] )
     ]
  ] [
     fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ;
     fhir:value [
       a fhir:code ;
       fhir:v "trial-use" ;
       fhir:extension ( [
         fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
         fhir:value [
           a fhir:canonical ;
           fhir:v "http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix"^^xsd:anyURI ;
           fhir:link <http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix>
         ]
       ] )
     ]
  ] ) ; # 
  fhir:url [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "0.1.0"] ; # 
  fhir:name [ fhir:v "APIXBusinessStatusCS"] ; # 
  fhir:title [ fhir:v "APIX Regulatory Business Status"] ; # 
  fhir:status [ fhir:v "draft"] ; # 
  fhir:experimental [ fhir:v false] ; # 
  fhir:date [ fhir:v "2026-10-19T12:20:49+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # 
  fhir:contact ( [
     fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
     fhir:telecom ( [
       fhir:system [ fhir:v "url" ] ;
       fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]
     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Code system for regulatory business status in APIX submissions"] ; # 
  fhir:jurisdiction ( [
     fhir:coding ( [
       fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ;
       fhir:code [ fhir:v "001" ] ;
       fhir:display [ fhir:v "World" ]
     ] )
  ] ) ; # 
  fhir:caseSensitive [ fhir:v true] ; # 
  fhir:content [ fhir:v "complete"] ; # 
  fhir:count [ fhir:v "22"^^xsd:nonNegativeInteger] ; # 
  fhir:concept ( [
     fhir:code [ fhir:v "submitted" ] ;
     fhir:display [ fhir:v "Submitted" ] ;
     fhir:definition [ fhir:v "The application has been submitted by the applicant." ]
  ] [
     fhir:code [ fhir:v "received" ] ;
     fhir:display [ fhir:v "Received" ] ;
     fhir:definition [ fhir:v "The application or submission has been received by the regulator." ]
  ] [
     fhir:code [ fhir:v "validation-successful" ] ;
     fhir:display [ fhir:v "Validation Successful" ] ;
     fhir:definition [ fhir:v "The technical and administrative validation has been completed successfully." ]
  ] [
     fhir:code [ fhir:v "validation-failed" ] ;
     fhir:display [ fhir:v "Validation Failed" ] ;
     fhir:definition [ fhir:v "The submission failed validation and cannot proceed." ]
  ] [
     fhir:code [ fhir:v "under-assessment" ] ;
     fhir:display [ fhir:v "Under Assessment" ] ;
     fhir:definition [ fhir:v "The submission is currently undergoing scientific review." ]
  ] [
     fhir:code [ fhir:v "clock-stop" ] ;
     fhir:display [ fhir:v "Clock Stop" ] ;
     fhir:definition [ fhir:v "The review timeline is paused, typically waiting for applicant response to questions." ]
  ] [
     fhir:code [ fhir:v "clock-restart" ] ;
     fhir:display [ fhir:v "Clock Restart" ] ;
     fhir:definition [ fhir:v "The review timeline has resumed following receipt of a response." ]
  ] [
     fhir:code [ fhir:v "consolidated-review" ] ;
     fhir:display [ fhir:v "Consolidated Review" ] ;
     fhir:definition [ fhir:v "Comments from multiple assessors are being consolidated." ]
  ] [
     fhir:code [ fhir:v "decision-pending" ] ;
     fhir:display [ fhir:v "Decision Pending" ] ;
     fhir:definition [ fhir:v "The assessment is complete and the final decision is being prepared." ]
  ] [
     fhir:code [ fhir:v "approved" ] ;
     fhir:display [ fhir:v "Approved" ] ;
     fhir:definition [ fhir:v "The application has been approved." ]
  ] [
     fhir:code [ fhir:v "rejected" ] ;
     fhir:display [ fhir:v "Rejected" ] ;
     fhir:definition [ fhir:v "The application has been rejected." ]
  ] [
     fhir:code [ fhir:v "withdrawn" ] ;
     fhir:display [ fhir:v "Withdrawn" ] ;
     fhir:definition [ fhir:v "The application has been withdrawn by the applicant." ]
  ] [
     fhir:code [ fhir:v "payment-requested" ] ;
     fhir:display [ fhir:v "Payment Requested" ] ;
     fhir:definition [ fhir:v "A fee payment has been requested by the regulator." ]
  ] [
     fhir:code [ fhir:v "payment-received" ] ;
     fhir:display [ fhir:v "Payment Received" ] ;
     fhir:definition [ fhir:v "The fee payment has been received and confirmed." ]
  ] [
     fhir:code [ fhir:v "icsr-accepted" ] ;
     fhir:display [ fhir:v "Report Accepted (CA)" ] ;
     fhir:definition [ fhir:v "The individual report was accepted. ICH E2B(R3) report acknowledgment code CA (ACK.B.r.6)." ]
  ] [
     fhir:code [ fhir:v "request-for-information-issued" ] ;
     fhir:display [ fhir:v "Request for Information Issued" ] ;
     fhir:definition [ fhir:v "The regulator has sent a request for information to the sponsor." ]
  ] [
     fhir:code [ fhir:v "authorised" ] ;
     fhir:display [ fhir:v "Authorised" ] ;
     fhir:definition [ fhir:v "The trial or modification has been authorised." ]
  ] [
     fhir:code [ fhir:v "labelling-comments-issued" ] ;
     fhir:display [ fhir:v "Labelling Comments Issued" ] ;
     fhir:definition [ fhir:v "The regulator has returned comments or a revised version to the applicant." ]
  ] [
     fhir:code [ fhir:v "counter-proposal-received" ] ;
     fhir:display [ fhir:v "Counter-Proposal Received" ] ;
     fhir:definition [ fhir:v "The applicant has returned a counter-proposal on the product information." ]
  ] [
     fhir:code [ fhir:v "response-received" ] ;
     fhir:display [ fhir:v "Response Received" ] ;
     fhir:definition [ fhir:v "The applicant’s response has been received." ]
  ] [
     fhir:code [ fhir:v "awaiting-applicant-response" ] ;
     fhir:display [ fhir:v "Awaiting Applicant Response" ] ;
     fhir:definition [ fhir:v "The regulator is waiting for the applicant to respond." ]
  ] [
     fhir:code [ fhir:v "labelling-agreed" ] ;
     fhir:display [ fhir:v "Labelling Agreed" ] ;
     fhir:definition [ fhir:v "Applicant and regulator have agreed the product information text." ]
  ] ) . #