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