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

Terminology

Page standards status: Informative

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This page shows example values for the four Task elements that carry regulatory meaning, grouped by domain: Market Authorization, Clinical Trials, and Individual Case Safety Reports (ICSR).

How the terminology is organised

There are three code systems. Each domain section below has an example value set for each of the four Task elements.

Task element	Code system (id)	Example value sets per domain
Task.code	apix-task-code	apix-ma-task-code-vs, apix-ct-task-code-vs, apix-icsr-task-code-vs
Task.businessStatus	apix-business-status	apix-ma-business-status-vs, apix-ct-business-status-vs, apix-icsr-business-status-vs
Task.input.type	apix-task-input-output-type	apix-ma-task-input-type-vs, apix-ct-task-input-type-vs, apix-icsr-task-input-type-vs
Task.output.type	apix-task-input-output-type (same code system)	apix-ma-task-output-type-vs, apix-ct-task-output-type-vs, apix-icsr-task-output-type-vs

Conventions used throughout:

• Inputs come from the requester, outputs from the owner. The party that creates the Task supplies Task.input; the party that does the work returns Task.output. For example, on a Payment Task created by the regulator, the invoice is an input and the proof of payment is an output.
• One code system for input and output types. The same document type can be an input on one Task and an output on another (for example, proposed labelling or a questionnaire response), so input and output types share one code system and differ only by value set.
• Task codes are hierarchical. Grouping codes (marked grouping) organise the Market Authorization sub-areas and the domain roots, so a value set can include a whole branch.
• Shared terms. Some business statuses and input/output types apply to every domain. They are listed once, in Shared terms, and included in each domain's value sets.

Shared terms

Used by all three domains.

Business status (shared)

Code	Display	Definition
submitted	Submitted	The application has been submitted by the applicant.
received	Received	The application or submission has been received by the regulator.
receipt-acknowledged	Receipt Acknowledged	Receipt has been formally acknowledged to the sender.
validation-successful	Validation Successful	The technical and administrative validation has been completed successfully.
validation-failed	Validation Failed	The submission failed validation and cannot proceed.
under-assessment	Under Assessment	The submission is currently undergoing scientific review.
clock-stop	Clock Stop	The review timeline is paused, typically waiting for applicant response to questions.
clock-restart	Clock Restart	The review timeline has resumed following receipt of a response.
consolidated-review	Consolidated Review	Comments from multiple assessors are being consolidated.
decision-pending	Decision Pending	The assessment is complete and the final decision is being prepared.
approved	Approved	The application has been approved.
rejected	Rejected	The application has been rejected.
withdrawn	Withdrawn	The application has been withdrawn by the applicant.

Input and output types (shared)

Code	Display	Definition
cover-letter	Cover Letter	Letter describing the submission and its contents.
application-form	Application Form	Completed regional application form.
supporting-document	Supporting Document	Any other document supporting the Task.
acknowledgment-of-receipt	Acknowledgment of Receipt	Confirmation that the submission was received.
validation-report	Validation Report	Outcome of technical or administrative validation.
assessment-report	Assessment Report	Regulator’s assessment of the submission.
decision-letter	Decision Letter	Formal communication of the regulatory decision.
questionnaire	Questionnaire	Structured list of questions.
questionnaire-response	Questionnaire Response	Structured answers to a questionnaire.
correspondence	Correspondence	General correspondence between the parties.

Market Authorization

Task codes — apix-ma-task-code-vs

Code	Display	Definition
market-authorization (grouping)	Market Authorization	Grouping: Tasks for the marketing authorization lifecycle of a human biopharmaceutical product.

Pre-submission

Code	Display	Definition
pre-submission (grouping)	Pre-Submission	Grouping: interactions before a marketing application is filed.
pre-submission-meeting-request	Pre-Submission Meeting Request	Request for a meeting with the regulator before filing (e.g., FDA pre-NDA/Type B meeting, EMA pre-submission meeting, Health Canada pre-submission meeting).
scientific-advice-request	Scientific Advice Request	Request for scientific or regulatory advice on development or the planned application (e.g., EMA scientific advice / protocol assistance, FDA Type C meeting).
eligibility-request	Eligibility Request	Request to confirm eligibility for a procedure or route (e.g., EU centralised procedure eligibility).
designation-request	Designation Request	Request for a designation or expedited pathway (e.g., orphan, breakthrough therapy, PRIME, priority review).
notice-of-intent-to-submit	Notice of Intent to Submit	Notification of the planned submission date and scope of a marketing application.

NDA/MAA

Code	Display	Definition
marketing-application (grouping)	Marketing Application (NDA/MAA)	Grouping: the initial marketing application and the regulator activities that process it.
initial-submission	Initial Submission	First submission of a new application or major variation.
new-drug-application	New Drug Application (NDA)	Initial marketing application for a new drug (US NDA; analogous national applications).
biologics-license-application	Biologics License Application (BLA)	Initial marketing application for a biological product (US BLA).
marketing-authorisation-application	Marketing Authorisation Application (MAA)	Initial application for a marketing authorisation (e.g., EU centralised, decentralised, or national procedure).
acknowledge-receipt	Acknowledge Receipt	Regulator confirms the submission was received and is technically readable.
validate-submission	Validate Submission	Technical and administrative validation (completeness) of a submission.
filing-review	Filing Review	Regulator decides whether the application is sufficiently complete to be filed for review (e.g., FDA 60-day filing review).
assess-application	Assess Application	Scientific assessment of the application (quality, non-clinical, clinical, labelling).
issue-regulatory-decision	Issue Regulatory Decision	Preparation and issue of the final regulatory action (approval, complete response, refusal).
resubmission	Resubmission	Applicant resubmits an application after a negative or complete-response decision.
appeal	Appeal / Re-examination	Applicant requests formal dispute resolution, re-examination, or appeal of a decision.
withdrawal	Withdrawal by Applicant	Applicant withdraws the procedure.

Payments

Code	Display	Definition
payment (grouping)	Payments	Grouping: fees and payments linked to a regulatory procedure.
assess-fee	Assess Fee	Regulator determines the fee due for a submission.
request-payment	Request Payment	Requested payment of regulatory fees.
fee-waiver-request	Fee Waiver or Reduction Request	Applicant requests a waiver, reduction, or deferral of fees.
refund-request	Refund Request	Applicant requests a refund of fees paid.

Question and response

Code	Display	Definition
question-and-response (grouping)	Question and Response	Grouping: questions raised during a procedure and the responses to them.
information-request	List of Questions / Information Request	Regulator raises questions or requests additional data.
list-of-outstanding-issues	List of Outstanding Issues	Regulator issues the issues that remain unresolved after the first round of questions (e.g., EU LoOI).
clarification-request	Clarification Request	Regulator requests a minor clarification that does not stop the clock.
response-timeline-extension-request	Response Timeline Extension Request	Applicant requests more time to respond to questions (clock-stop extension).

Label negotiation

Code	Display	Definition
label-negotiation (grouping)	Label Negotiation	Grouping: agreement of the product information (labelling) text between applicant and regulator, for initial applications and post-approval label changes.
labelling-proposal	Labelling Proposal	Applicant submits proposed product information, or a counter-proposal, for review.
labelling-comments	Labelling Comments	Regulator returns comments on, or a revised version of, the proposed product information for the applicant to accept or counter-propose.
labelling-agreement	Labelling Agreement	Regulator and applicant confirm the final agreed product information text.

Post-approval changes

Code	Display	Definition
post-approval-change (grouping)	Post-Approval Change	Grouping: changes to an authorized product and lifecycle maintenance.
supplement	Supplement / Variation	Post-authorization change (Type IA, IB, II, extension, etc.).
variation-type-ia	Type IA Variation	Minor "do and tell" change notified after implementation (EU).
variation-type-ib	Type IB Variation	Minor, post-approval change to a medicinal product's marketing authorization that has minimal impact on quality, safety, or efficacy
variation-type-ii	Type II Variation	Major change that may significantly affect quality, safety, or efficacy (EU).
line-extension	Line Extension	Extension of a marketing authorisation (e.g., new strength, pharmaceutical form, or route).
prior-approval-supplement	Prior Approval Supplement (PAS)	Major change requiring approval before distribution (US).
cbe-30	Changes Being Effected in 30 Days (CBE-30)	Moderate change that may be distributed 30 days after receipt (US).
cbe-0	Changes Being Effected (CBE-0)	Moderate change that may be distributed on receipt (US).
annual-report	Annual / Periodic Report (Authorized Product)	Periodic report for an authorized product (e.g., PSUR/PBRER, US NDA/BLA annual report). Clinical-trial annual reports use annual-safety-report.
renewal	Renewal	Renewal of a marketing authorisation.
marketing-authorisation-transfer	Marketing Authorisation Transfer	Transfer of a marketing authorisation to a new holder.

Business status — apix-ma-business-status-vs

Domain-specific statuses:

Code	Display	Definition
meeting-granted	Meeting Granted	The requested meeting has been granted and scheduled.
meeting-denied	Meeting Denied	The requested meeting has been denied.
written-response-only	Written Response Only	The regulator will answer the meeting questions in writing instead of meeting.
preliminary-responses-issued	Preliminary Responses Issued	Preliminary written responses to the meeting questions have been issued.
meeting-held	Meeting Held	The meeting has taken place.
minutes-issued	Minutes Issued	Final meeting minutes or advice letter have been issued.
designation-granted	Designation Granted	The requested designation or eligibility has been granted or confirmed.
designation-denied	Designation Denied	The requested designation or eligibility has been denied.
filing-review-underway	Filing Review Underway	The regulator is deciding whether to file the application for review.
filed-accepted-for-review	Filed — Accepted for Review	The application has been filed and accepted for substantive review.
refused-to-file	Refused to File	The application was not accepted for review.
complete-response-issued	Complete Response Issued	The review cycle ended without approval; deficiencies were communicated (e.g., FDA complete response letter).
resubmission-received	Resubmission Received	A resubmission following a complete response or refusal has been received.
appeal-submitted	Appeal Submitted	An appeal, re-examination, or dispute-resolution request has been submitted.
appeal-under-review	Appeal Under Review	The appeal is being reviewed.
appeal-decision-issued	Appeal Decision Issued	The outcome of the appeal has been issued.
fee-assessment-underway	Fee Assessment Underway	The regulator is determining the fee due.
payment-requested	Payment Requested	A fee payment has been requested by the regulator.
payment-received	Payment Received	The fee payment has been received and confirmed.
payment-overdue	Payment Overdue	The fee payment was not received by the due date.
fee-waiver-granted	Fee Waiver Granted	The fee waiver, reduction, or deferral has been granted.
fee-waiver-denied	Fee Waiver Denied	The fee waiver, reduction, or deferral has been denied.
refund-issued	Refund Issued	A fee refund has been issued.
questions-issued	Questions Issued	Questions or an information request have been sent to the applicant.
awaiting-applicant-response	Awaiting Applicant Response	The regulator is waiting for the applicant to respond.
response-received	Response Received	The applicant’s response has been received.
response-under-review	Response Under Review	The regulator is reviewing the applicant’s response.
response-accepted	Response Accepted	The response resolves the questions raised.
further-information-required	Further Information Required	The response did not resolve all questions; further information is needed.
extension-granted	Extension Granted	A requested extension of the response timeline has been granted.
extension-denied	Extension Denied	A requested extension of the response timeline has been denied.
labelling-under-review	Labelling Under Review	The regulator is reviewing the proposed product information.
labelling-comments-issued	Labelling Comments Issued	The regulator has returned comments or a revised version to the applicant.
counter-proposal-received	Counter-Proposal Received	The applicant has returned a counter-proposal on the product information.
labelling-agreed	Labelling Agreed	Applicant and regulator have agreed the product information text.
notification-accepted	Notification Accepted	A notified change (e.g., Type IA) has been accepted.
change-implemented	Change Implemented	The approved change has been implemented.

Also included from shared terms: submitted, received, receipt-acknowledged, validation-successful, validation-failed, under-assessment, clock-stop, clock-restart, consolidated-review, decision-pending, approved, rejected, withdrawn.

Typical progressions:

• Pre-submission meeting: submitted → received → meeting-granted (or written-response-only / meeting-denied) → preliminary-responses-issued → meeting-held → minutes-issued

• NDA/MAA: submitted → received → receipt-acknowledged → validation-successful → filing-review-underway → filed-accepted-for-review → under-assessment → (clock-stop ↔ clock-restart) → decision-pending → approved

  complete-response-issued

  rejected

• Payment: fee-assessment-underway → payment-requested → payment-received (or payment-overdue)

• Question and response: questions-issued → awaiting-applicant-response → response-received → response-under-review → response-accepted

  further-information-required

• Label negotiation: labelling-under-review → labelling-comments-issued → counter-proposal-received → (repeat) → labelling-agreed
• Post-approval change: submitted → received → validation-successful → under-assessment → decision-pending → approved → change-implemented (Type IA: submitted → notification-accepted)

Worked example: a Type II variation with two rounds of label negotiation on an annotated ePI — submitted, validated, under assessment, labelling comments round 1, counter-proposal, labelling comments round 2, response, agreement requested, labelling agreed, approved.

Input and output types — apix-ma-task-input-type-vs / apix-ma-task-output-type-vs

Domain-specific types:

Code	Display	Definition
meeting-request-letter	Meeting Request Letter	Request for a meeting, with proposed format and date.
briefing-package	Briefing Package	Background document and the sponsor’s questions for a meeting or advice request.
preliminary-responses	Preliminary Responses	Regulator’s preliminary written answers to meeting questions.
meeting-minutes	Meeting Minutes	Final record of a meeting or advice outcome.
designation-decision	Designation Decision	Decision on a designation or eligibility request.
ectd-sequence	eCTD Sequence	An eCTD submission sequence (backbone and documents).
cmc-documents	CMC Documents	Chemistry, manufacturing, and controls documentation.
stability-data	Stability Data	Stability study data and summaries.
clinical-study-report	Clinical Study Report	Clinical study report supporting the application.
risk-management-plan	Risk Management Plan	Risk management plan or REMS.
epi-bundle	ePI Bundle	Electronic product information as a FHIR document Bundle.
proposed-labelling	Proposed Labelling	Proposed product information (e.g., annotated PDF or Word).
labelling-comments	Labelling Comments	Regulator’s comments on, or revised version of, proposed labelling.
approved-labelling	Approved Labelling	Final agreed product information.
invoice	Invoice	Fee invoice issued by the regulator.
proof-of-payment	Proof of Payment	Evidence that the fee has been paid.
fee-waiver-justification	Fee Waiver Justification	Justification for a fee waiver, reduction, or deferral.
payment-receipt	Payment Receipt	Regulator’s confirmation that payment was received.
list-of-questions	List of Questions	Questions or information request from the regulator.
response-to-questions	Response to Questions	Applicant’s response document to a list of questions.
change-description	Change Description and Justification	Description of the proposed change, with current vs proposed comparison and justification.
complete-response-letter	Complete Response Letter	Letter describing the deficiencies that prevent approval.
approval-letter	Approval Letter	Letter granting approval or authorization.

Value set membership (including shared types):

Code	Display	Input	Output
cover-letter	Cover Letter	✓
application-form	Application Form	✓
supporting-document	Supporting Document	✓
acknowledgment-of-receipt	Acknowledgment of Receipt		✓
validation-report	Validation Report		✓
assessment-report	Assessment Report		✓
decision-letter	Decision Letter		✓
questionnaire	Questionnaire	✓
questionnaire-response	Questionnaire Response		✓
correspondence	Correspondence		✓
meeting-request-letter	Meeting Request Letter	✓
briefing-package	Briefing Package	✓
preliminary-responses	Preliminary Responses		✓
meeting-minutes	Meeting Minutes		✓
designation-decision	Designation Decision		✓
ectd-sequence	eCTD Sequence	✓
cmc-documents	CMC Documents	✓
stability-data	Stability Data	✓
clinical-study-report	Clinical Study Report	✓
risk-management-plan	Risk Management Plan	✓
epi-bundle	ePI Bundle	✓	✓
proposed-labelling	Proposed Labelling	✓	✓
labelling-comments	Labelling Comments	✓	✓
approved-labelling	Approved Labelling		✓
invoice	Invoice	✓
proof-of-payment	Proof of Payment		✓
fee-waiver-justification	Fee Waiver Justification	✓
payment-receipt	Payment Receipt		✓
list-of-questions	List of Questions	✓	✓
response-to-questions	Response to Questions		✓
change-description	Change Description and Justification	✓
complete-response-letter	Complete Response Letter		✓
approval-letter	Approval Letter		✓

Clinical Trials

Task codes — apix-ct-task-code-vs

Code	Display	Definition
clinical-trial (grouping)	Clinical Trial	Grouping: regulatory interactions for clinical trials of human biopharmaceutical products.
clinical-trial-application	Clinical Trial Application	Initial application to conduct a clinical trial (e.g., EU CTA under CTR, US IND, Health Canada CTA).
add-member-state	Addition of Member State Concerned	Extension of an authorized trial to an additional member state (EU CTR).
substantial-modification	Substantial Modification / Protocol Amendment	Change likely to substantially affect participant safety or rights, or data reliability; requires authorization (EU) or amendment submission (US).
non-substantial-modification	Non-Substantial Modification	Change that does not require authorization but must be recorded or notified.
information-amendment	Information Amendment	Submission of essential new information that is not a protocol amendment (US IND).
trial-start-notification	Trial Start Notification	Notification of start of trial or first participant visit.
end-of-recruitment-notification	End of Recruitment Notification	Notification that recruitment has ended.
temporary-halt-notification	Temporary Halt Notification	Notification that the trial has been temporarily halted.
restart-request	Restart After Temporary Halt	Request to restart a trial after a temporary halt.
early-termination-notification	Early Termination Notification	Notification that the trial ended early.
end-of-trial-notification	End of Trial Notification	Notification that the trial has ended.
urgent-safety-measure	Urgent Safety Measure	Notification of an urgent safety measure taken to protect participants.
serious-breach-notification	Serious Breach Notification	Notification of a serious breach of the protocol or GCP.
annual-safety-report	Annual Safety Report (Clinical Trial)	Annual report for an investigational product under clinical development (e.g., DSUR, US IND annual report). Authorized-product periodic reports use annual-report.
clinical-trial-results-summary	Clinical Trial Results Summary	Summary of results (and lay summary) after the end of the trial.
clinical-hold	Clinical Hold	Regulator orders a delay or suspension of a proposed or ongoing trial (US IND).
clinical-hold-response	Complete Response to Clinical Hold	Sponsor responds to all clinical hold issues and requests that the hold be lifted.

Also included from Market Authorization: information-request, withdrawal.

Business status — apix-ct-business-status-vs

Domain-specific statuses:

Code	Display	Definition
request-for-information-issued	Request for Information Issued	The regulator has sent a request for information to the sponsor.
authorised	Authorised	The trial or modification has been authorised.
authorised-with-conditions	Authorised with Conditions	The trial or modification has been authorised subject to conditions.
not-authorised	Not Authorised	The trial or modification has not been authorised.
may-proceed	May Proceed	The review period has ended without objection and the trial may proceed (e.g., US IND 30-day review).
on-clinical-hold	On Clinical Hold	The trial is on clinical hold.
clinical-hold-lifted	Clinical Hold Lifted	The clinical hold has been lifted.
trial-ongoing	Trial Ongoing	The trial has started and is ongoing.
recruitment-ended	Recruitment Ended	Recruitment has ended.
temporarily-halted	Temporarily Halted	The trial is temporarily halted.
trial-ended	Trial Ended	The trial has ended.
terminated-early	Terminated Early	The trial was terminated early.
results-submitted	Results Submitted	The results summary has been submitted.

Also included from shared terms: submitted, received, receipt-acknowledged, validation-successful, validation-failed, under-assessment, clock-stop, clock-restart, decision-pending, withdrawn.

Typical progressions:

• Clinical trial application: submitted → received → validation-successful → under-assessment → (request-for-information-issued: clock-stop ↔ clock-restart) → authorised

  authorised-with-conditions

  not-authorised; US IND: received → may-proceed

  on-clinical-hold

• Trial lifecycle: authorised → trial-ongoing → recruitment-ended → trial-ended → results-submitted (or temporarily-halted / terminated-early)

Worked example: a clinical trial application from submission to authorisation, including a request for information — submission, validated, request for information, response, authorised.

Input and output types — apix-ct-task-input-type-vs / apix-ct-task-output-type-vs

Domain-specific types:

Code	Display	Definition
protocol	Protocol	Clinical trial protocol (or amended protocol).
protocol-synopsis	Protocol Synopsis	Summary of the protocol.
investigators-brochure	Investigator’s Brochure	Investigator’s brochure.
impd	Investigational Medicinal Product Dossier	IMPD or equivalent quality/non-clinical/clinical data for the investigational product.
informed-consent-form	Informed Consent Form	Participant information sheet and informed consent form.
modification-description	Modification Description	Description and justification of a modification, with tracked changes.
dsur	DSUR	Development Safety Update Report.
results-summary	Results Summary	Summary of clinical trial results.
lay-summary	Lay Summary	Summary of results for a lay audience.
request-for-information	Request for Information	Questions from the regulator during assessment of a trial.
authorisation-decision	Authorisation Decision	Decision on a clinical trial application or modification.
clinical-hold-letter	Clinical Hold Letter	Letter describing the reasons for a clinical hold.

Value set membership (including shared types):

Code	Display	Input	Output
cover-letter	Cover Letter	✓
application-form	Application Form	✓
supporting-document	Supporting Document	✓
acknowledgment-of-receipt	Acknowledgment of Receipt		✓
validation-report	Validation Report		✓
assessment-report	Assessment Report		✓
decision-letter	Decision Letter		✓
questionnaire	Questionnaire	✓
questionnaire-response	Questionnaire Response		✓
correspondence	Correspondence		✓
response-to-questions	Response to Questions		✓
protocol	Protocol	✓
protocol-synopsis	Protocol Synopsis	✓
investigators-brochure	Investigator’s Brochure	✓
impd	Investigational Medicinal Product Dossier	✓
informed-consent-form	Informed Consent Form	✓
modification-description	Modification Description	✓
dsur	DSUR	✓
results-summary	Results Summary	✓
lay-summary	Lay Summary	✓
request-for-information	Request for Information	✓	✓
authorisation-decision	Authorisation Decision		✓
clinical-hold-letter	Clinical Hold Letter		✓

Individual Case Safety Reports (ICSR)

Task codes — apix-icsr-task-code-vs

Code	Display	Definition
icsr (grouping)	Individual Case Safety Report	Grouping: transmission of individual case safety reports as ICH E2B(R3) messages and the acknowledgments that follow.
icsr-initial	Initial ICSR	First ICH E2B(R3) report of a case, identified by its worldwide unique case identification number (C.1.8.1).
icsr-follow-up	Follow-up ICSR	ICH E2B(R3) report with new information for a case already reported; same worldwide unique case identification number (C.1.8.1) and a later date of most recent information (C.1.5).
icsr-amendment	ICSR Amendment	ICH E2B(R3) report that corrects a previously sent report without new medical information (C.1.11.1 = Amendment, reason in C.1.11.2).
icsr-nullification	ICSR Nullification	ICH E2B(R3) report that nullifies a previously sent report, for example a duplicate or invalid case (C.1.11.1 = Nullification, reason in C.1.11.2).
susar-report	SUSAR Report	Expedited ICH E2B(R3) report of a suspected unexpected serious adverse reaction in a clinical trial (e.g., EU CTR SUSAR, US IND safety report).
follow-up-information-request	Follow-up Information Request	Receiver asks the sender for additional information on a case.

Also included from Market Authorization: withdrawal.

Business status — apix-icsr-business-status-vs

Domain-specific statuses:

Code	Display	Definition
transmission-accepted	Transmission Accepted (AA)	All reports in the message were loaded. ICH E2B(R3) transmission acknowledgment code AA (ACK.A.4).
transmission-partially-accepted	Transmission Partially Accepted (AE)	The message was processed but one or more reports were not loaded. ICH E2B(R3) transmission acknowledgment code AE (ACK.A.4).
transmission-rejected	Transmission Rejected (AR)	The message could not be processed and no reports were loaded. ICH E2B(R3) transmission acknowledgment code AR (ACK.A.4).
icsr-accepted	Report Accepted (CA)	The individual report was accepted. ICH E2B(R3) report acknowledgment code CA (ACK.B.r.6).
icsr-rejected	Report Rejected (CR)	The individual report was rejected. ICH E2B(R3) report acknowledgment code CR (ACK.B.r.6).
follow-up-requested	Follow-up Requested	The receiver has requested more information on the case.
duplicate-identified	Duplicate Identified	The case was identified as a duplicate of an existing case.
case-nullified	Case Nullified	A nullification report for the case has been accepted.

Also included from shared terms: submitted, received, receipt-acknowledged, validation-failed, withdrawn.

Typical progressions:

• ICSR: submitted → received → transmission-accepted (AA)

  transmission-partially-accepted (AE)

  transmission-rejected (AR); then, for each report, icsr-accepted (CA)

  icsr-rejected (CR) → (follow-up-requested)

Worked example: an initial and a follow-up ICSR with their E2B(R3) acknowledgments — initial, acknowledged, follow-up, acknowledged.

Input and output types — apix-icsr-task-input-type-vs / apix-icsr-task-output-type-vs

Domain-specific types:

Code	Display	Definition
icsr-message	ICSR Message	ICH E2B(R3) ICSR message containing one or more case safety reports.
source-document	Source Document	Document supporting a case, such as a literature article or medical records (ICH E2B(R3) included documents, C.1.6.1.r.2 and C.4.r.2).
icsr-acknowledgment	ICSR Acknowledgment	ICH E2B(R3) acknowledgment message returned for an ICSR message, carrying the transmission (ACK.A.4) and report (ACK.B.r.6) acknowledgment codes.
follow-up-questions	Follow-up Questions	Questions about a case sent by the receiver.
follow-up-response	Follow-up Response	Answers to follow-up questions about a case.

Value set membership (including shared types):

Code	Display	Input	Output
cover-letter	Cover Letter	✓
supporting-document	Supporting Document	✓
correspondence	Correspondence		✓
icsr-message	ICSR Message	✓
source-document	Source Document	✓
icsr-acknowledgment	ICSR Acknowledgment		✓
follow-up-questions	Follow-up Questions	✓
follow-up-response	Follow-up Response		✓

The content of the ICSR itself (case, reporter, reactions, drugs) stays in the ICH E2B(R3) message carried as icsr-message. These codes only describe the exchange around it.