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
| Page standards status: Informative |
Profile: APIX Regulatory DocumentReference
identifier: Document Set Identifier/urn:uuid:2460574f-c235-510e-bc4c-96e063c30df2, Document Version Number Identifier/urn:uuid:c79a91e1-9537-5933-82dd-7ccf8e9e4eb0
version: 1
status: Current
docStatus: Final
type: ICSR Message
date: 2026-10-02 09:30:00+0200
author: SynthPharma AG
description:
Initial ICH E2B(R3) ICSR for case CH-SYNTHPHARMA-2026-000456 (nausea with WonderDrug 50 mg).
content
Attachments
ContentType Url Size Hash Title Creation application/xml Binary: application/xml (10720 bytes base64) 8038 S+dAYt27+1cEPbqbQxUmGUOT98o=icsr-initial.xml 2026-10-02 09:30:00+0200