API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build

API for the Exchange of Medicinal Product Information (APIX), published by Gravitate Health Project. 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

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

APIX Regulatory DocumentReference (base64 only)

DocumentReference profile used in APIX regulatory submissions. All documents are fully embedded as base64 (no external URLs allowed) and categorized with CTD section headings.

APIX Regulatory Task

Task profile for APIX regulatory submission workflows

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

APIX Regulatory Business Status
APIX Task Codes ValueSet
APIX Task Input Types

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

APIX CTD/eCTD Section Code System

Code system defining all relevant CTD/eCTD section codes used in APIX regulatory submissions to EMA, FDA, PMDA and other agencies. Based on ICH M4 guidelines.

APIX Regulatory Business Status
APIX Task Code System

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

Example Task - scenario1-01b-stability-update-1
Example Task - scenario1-01c-stability-update-2
Example Task - task-nda-submission-index-2025
scenario1-01-initial-submission
scenario1-02-validation
scenario1-03-finance-invoice
scenario1-04-finance-payment
scenario1-05-technical-question
scenario1-06-technical-response
scenario1-07-final-decision
task-shelf-life-extension-synthpharma-2025