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