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

API for the Exchange of Medicinal Product Information (APIX), 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

Getting Started

Page standards status: Informative

Getting Started with APIX

Five simple steps to connect your systems to a regulator. Each step builds on the previous one — start at the top and work your way down.

1
Step 1
Connect via API

Register your Organization and Endpoint on the regulator's FHIR server. This tells the regulator who you are and where to send notifications back to you.

💡 Think of it like…
Registering a shipping address before you can send or receive packages. You only do this once.
✅ Business benefit: One-time setup — connects your company to any regulator that supports APIX.
2
Step 2
Stream Files as Binary

Upload any file type — PDF, DOCX, XML, JSON, data sets — to the regulator's FHIR server as a Binary resource. Files are stored securely and accessed on-demand by the reviewer.

💡 Think of it like…
Netflix for documents. Instead of mailing a box of DVDs (a giant ZIP file), each document is streamed individually — the reviewer only downloads what they need, when they need it.
✅ Business benefit: No more massive portal uploads. Sub-second processing instead of hours of waiting.
3
Step 3
Describe with DocumentReference

For each Binary you uploaded, create a DocumentReference resource that captures metadata — the file's category, version, type, and CTD section. This lets the regulator search, filter, and discover your documents without downloading them.

💡 Think of it like…
A library catalog card. The card describes the book (title, author, subject) so you can find it without reading every book on the shelf.
✅ Business benefit: Reviewers instantly find the exact document they need. No more searching through ZIP files.
4
Step 4
Orchestrate with Task

Create a FHIR Task resource to initiate and track a regulatory activity — any type of activity, for any type of regulated product. The Task references your DocumentReferences and progresses through status changes as the procedure advances.

💡 Think of it like…
A FedEx tracking number. You create the shipment (Task), attach the packages (documents), and then both sender and receiver can track exactly where it is in the process at every step.
✅ Business benefit: Every date and time is recorded. After the procedure, analyze and visualize cycle times across one or many regulatory activities.
What can you track?
Clinical Trial Application MAA Shelf-life Update Label Update Invoice Payment Q&A Exchange Decision Letter
5
Step 5
Subscribe for Real-Time Updates

Set up a Subscription to receive instant notifications whenever Tasks are updated as the regulatory activity progresses. Both company and regulator subscribe — so both sides know immediately when something changes.

💡 Think of it like…
Package delivery notifications. You don't need to keep checking the website — you get a push notification the moment your package moves to the next step.
✅ Business benefit: No more logging into portals to check status. Your system is notified automatically in real-time.

Task Lifecycle

As a regulatory activity progresses, the Task's status moves through these stages. Each transition is timestamped, creating a complete audit trail.

draft
requested
received
accepted
in-progress
completed
📈
Cycle-Time Analytics

Because every status change is timestamped, you can analyze the duration of each phase across one or many regulatory procedures. Visualize bottlenecks, benchmark SLA performance, and identify opportunities to accelerate time-to-market for your products.

Choose Your Path

🏢
Pharmaceutical Industry

You want to automate regulatory submissions, track procedures in real-time, and eliminate manual portal uploads.

  1. Review the Use Cases
  2. Study the Workflow Overview
  3. Configure your RIM system for FHIR R5 Task-based exchange
  4. Test with the reference implementation
🏛️
Regulatory Authorities

You are building or modernizing your regulatory exchange infrastructure with API-first architecture.

  1. Review the Architecture
  2. Set up an R5-compliant FHIR server
  3. Configure SubscriptionTopics
  4. Test subscription notifications
💻
Technology Vendors

You are building RIM integrations, regulatory gateways, or FHIR server implementations for pharma and regulators.

  1. Study the FHIR Profiles
  2. Review the Interaction Pattern
  3. Implement the Task workflow
  4. Validate with the HL7 Validator

Prerequisites

Required
FHIR R5 Server

An R5-compliant FHIR server with support for Subscriptions, conditional create/update, and SMART Backend Services (e.g., HAPI FHIR, Smile CDR, Azure, AWS HealthLake, GCP Healthcare API).

Required
OAuth2 / SMART

SMART Backend Services for system-level authentication using JWT bearer tokens. Mandatory for production use to ensure secure, audited access.

Recommended
REST API Client

A REST client (e.g., Postman, cURL, or your RIM system) capable of sending FHIR JSON payloads over HTTPS. Essential for prototyping and testing.

Validate & Build

Once you have reviewed the architecture and workflow:

  1. Validate your FHIR resources — Use the Official FHIR Validator with the APIX IG package to check compliance with the profiles defined in this guide.
  2. Test end-to-end — Post a Task to a test FHIR server, subscribe to status changes, and verify that notifications arrive at your webhook endpoint.
  3. Connect your RIM — Use the provided examples as templates. Start with a simple shelf-life variation submission to establish connectivity.