  0 Table of Contents |
  1 Home |
| 2 Getting Started |
 3 Use Cases |
 3.1 Universal Submissions |
| 3.2 Submission Tracking and Notifications |
 3.3 Automation |
| 4 Workflow |
| 5 Notifications |
| 6 Architecture |
| 7 Interaction Pattern |
| 8 Terminology |
| 9 RWI-pharma Task Structure |
| 10 Subscription |
| 11 SubscriptionTopic |
| 12 Notification & Status |
| 13 Organization & Endpoint |
| 14 DocumentReference |
 15 Artifacts Summary |
 15.1 APIX Endpoint for FHIR Subscription Notifications |
| 15.2 APIX Organization |
| 15.3 APIX Regulatory DocumentReference |
| 15.4 APIX Regulatory Task |
| 15.5 APIX Subscription |
| 15.6 APIX Task Assignment and Creation With Organization Filter |
| 15.7 APIX Task Status Change With Identifier Filter |
| 15.8 APIX CTD/eCTD Module Value Set |
| 15.9 APIX Submission Types |
| 15.10 Value Set APIX CTD/eCTD Section Code System |
| 15.11 Value Set APIX Regulatory Business Status |
| 15.12 APIX CTD/eCTD Section Code System |
| 15.13 APIX Identifier Type Codes |
| 15.14 APIX Regulatory Business Status |
| 15.15 APIX Task Code System |
| 15.16 APIX Task Input and Output Types |
| 15.17 Temporary APIX Codes |
| 15.18 Acknowledgment of follow-up ICSR |
| 15.19 Acknowledgment of initial ICSR |
| 15.20 Annotated ePI v1 (proposal) |
| 15.21 Annotated ePI v2 (regulator comments, round 1) |
| 15.22 Annotated ePI v3 (counter-proposal, round 1) |
| 15.23 Annotated ePI v4 (regulator comments, round 2) |
| 15.24 Approved ePI |
| 15.25 Authorisation decision |
| 15.26 binary-1004 |
| 15.27 binary-1005 |
| 15.28 binary-1006 |
| 15.29 binary-cta-application-form |
| 15.30 binary-cta-cover-letter |
| 15.31 binary-cta-decision |
| 15.32 binary-cta-protocol |
| 15.33 binary-cta-rfi |
| 15.34 binary-cta-rfi-response |
| 15.35 binary-cta-validation-report |
| 15.36 binary-epi-annotated-v1 |
| 15.37 binary-epi-annotated-v2 |
| 15.38 binary-epi-annotated-v3 |
| 15.39 binary-epi-annotated-v4 |
| 15.40 binary-epi-clean-v1 |
| 15.41 binary-epi-clean-v3 |
| 15.42 binary-epi-clean-v5 |
| 15.43 binary-icsr-follow-up |
| 15.44 binary-icsr-follow-up-ack |
| 15.45 binary-icsr-initial |
| 15.46 binary-icsr-initial-ack |
| 15.47 binary-var-application-form |
| 15.48 binary-var-approval-letter |
| 15.49 binary-var-change-description |
| 15.50 binary-var-cover-letter |
| 15.51 binary-var-validation-report |
| 15.52 Change description and justification |
| 15.53 Clean ePI v1 (proposal) |
| 15.54 Clean ePI v3 (counter-proposal, round 1) |
| 15.55 Clean ePI v5 (agreed text) |
| 15.56 CTA application form |
| 15.57 CTA cover letter |
| 15.58 CTA validation report |
| 15.59 doc1 |
| 15.60 doc2 |
| 15.61 doc3 |
| 15.62 doc4 |
| 15.63 doc5 |
| 15.64 doc6 |
| 15.65 doc7 |
| 15.66 doc8 |
| 15.67 docref approval letter |
| 15.68 docref assessment report |
| 15.69 docref list of questions |
| 15.70 docref payment proof |
| 15.71 docref responses qresponse |
| 15.72 docref stability data annex |
| 15.73 Example APIX interaction Endpoint with header |
| 15.74 Example basic APIX interaction Endpoint |
| 15.75 Follow-up ICSR — case CH-SYNTHPHARMA-2026-000456 |
| 15.76 Initial ICSR — case CH-SYNTHPHARMA-2026-000456 |
| 15.77 Invoice for Regulatory Submission Review |
| 15.78 Organization example with Endpoint |
| 15.79 Organization Health Authority – Regulatory Review Division |
| 15.80 Organization SynthPharma AG |
| 15.81 output ack |
| 15.82 output validation |
| 15.83 Protocol WD-201 v1.0 |
| 15.84 Request for information |
| 15.85 Response to request for information |
| 15.86 scenario1 01 initial submission |
| 15.87 scenario1 02 validation |
| 15.88 scenario1 03 finance invoice original Task |
| 15.89 scenario1 04 finance payment reflected by invoice Task update |
| 15.90 scenario1 05 technical question |
| 15.91 scenario1 06 technical response |
| 15.92 scenario1-07-final-decision |
| 15.93 scenario2 01 initial ICSR submitted |
| 15.94 scenario2 02 initial ICSR acknowledged |
| 15.95 scenario2 03 follow-up ICSR submitted |
| 15.96 scenario2 04 follow-up ICSR acknowledged |
| 15.97 scenario3 01 clinical trial application submitted |
| 15.98 scenario3 02 clinical trial application validated |
| 15.99 scenario3 03 request for information issued |
| 15.100 scenario3 04 request for information answered |
| 15.101 scenario3 05 clinical trial authorised |
| 15.102 scenario4 01 Type II variation submitted |
| 15.103 scenario4 02 Type II variation validated |
| 15.104 scenario4 03 Type II variation under assessment |
| 15.105 scenario4 04 labelling comments round 1 issued |
| 15.106 scenario4 05 labelling comments round 1 answered with a counter-proposal |
| 15.107 scenario4 06 labelling comments round 2 issued |
| 15.108 scenario4 07 labelling comments round 2 accepted |
| 15.109 scenario4 08 labelling agreement requested |
| 15.110 scenario4 09 labelling agreed |
| 15.111 scenario4 10 Type II variation approved |
| 15.112 Subscription for Task Status Change with Identifier Filter |
| 15.113 SubscriptionNotification Task ID Only |
| 15.114 Task Assignment and Creation With Organization Filter |
| 15.115 Task Status Change With Identifier Filter |
| 15.116 Variation application form |
| 15.117 Variation approval letter |
| 15.118 Variation cover letter |
| 15.119 Variation validation report |
|
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