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

Plain Language Summary goes here

IG Home

Official URL: http://hl7.org/fhir/uv/rtq-ig/ImplementationGuide/hl7.fhir.uv.rtq-ig Version: 0.1.0
Draft as of 2025-12-06 Computable Name: ApixIG

Introduction

APIX is a HL7 FHIR R5 Implementation Guide that defines an all in one, standardised solution for exchanging medicinal-product data between industry, regulators, and healthcare systems worldwide.

Why Adopt APIX?

  1. One integration, all products & procedures
    Single FHIR framework covers every medicinal product type and every regulatory procedure — one connection at the agency reaches all companies; one connection at the company reaches all regulators.

  2. Built on the internet’s proven standards
    Same RESTful APIs and OAuth2 that already run Epic, Cerner, Apple Health, Stripe, and global banking. Zero proprietary formats or custom protocols.

  3. From months to seconds
    Submissions, questions, clock-stops, and decisions become real-time FHIR Tasks + Subscriptions. Cycle-time delays become visible and quickly fixable.

  4. Instant innovation platform
    Open APIs immediately enable AI agents, analytics tools, RIM/ERP integrations, and third-party apps — no extra gateways required.

  5. Free performance dashboards
    Every milestone is a timestamped FHIR Task. Run cycle-time KPIs, benchmarks, or SLA reports with one simple search — no extra BI tools needed.

Background

The exchange of medicinal-product information today is slow, manual, and fragmented. The regulatory lifecycle relies on a mix of portals, submission formats, email, and manual workflows.

APIX changes that by providing a single, harmonised, API-first layer that is built natively for the web; i.e., aligned with the same technologies as international healthcare, banking, finance, and eCommerce.

In Scope

Phase I (2025 / 2026) focuses on the following:

  • human medicinal products
  • Regulatory submissions & procedural management (e.g., variations, supplements, question and response)
  • Adverse Event Reporting (Individual case safety reports (ICSR))
  • Payment of application fees

Out of Scope

Phase II+ (2026+) will consider the following:

  • Remaining product types (Medical Devices, Veterinary drug, Over the counter drugs, Natural health products)
  • Clinical trials
  • Master file
  • Health Technology Assessment (HTA) dossiers
  • Establishment and inspection submissions (GMP, GCP, GLP facilities, audits, compliance)

IDMP identifier requests (e.g., Pharmaceutical Product Identifier (PhPID) and Global Substance Identifier (GSID)) – refer to the UMC IDMP Request and Publish API Implementation Guide for detail.

Governance & Collaboration

APIX is developed under the HL7 Vulcan Accelerator with active participation from regulators, pharmaceutical companies, and technology vendors.

All meetings are public; notes and recordings are available via HL7 Vulcan's APIX project page.

Get Involved

  • Join the weekly calls.
  • Test the reference implementation

We welcome industry, solution providers, and regulators from every region to contribute.