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

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Official URL: http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix Version: 0.1.0
Draft as of 2025-12-23 Computable Name: ApixIG

Introduction

APIX is the global standard for the automated, algorithmic exchange of medicinal product information. Built on HL7 FHIR R5, it creates a single, interoperable network connecting industry, regulators, and healthcare systems worldwide—replacing static documents with real-time data.

This guide defines the technical framework to make that vision a reality.

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 global banking, eCommerce, and modern healthcare (SMART on FHIR). Zero proprietary formats.

  3. From months to seconds
    Submissions, questions, and decisions become real-time events. Cycle-time delays become visible and instantly actionable.

  4. Instant innovation platform
    Open APIs enable AI agents, predictive analytics, and seamless RIM/ERP integrations—no custom gateways required.

  5. Universal performance tracking
    Every milestone is a timestamped event. Run cycle-time KPIs and SLA reports with one simple search across the entire submission portfolio.

Strategic Objectives

The APIX initiative is driven by two transformative goals:

1. Real-Time Algorithmic Exchange

We are moving from a document-centric regulatory world to a data-centric one. Today’s reliance on static PDF dossiers and periodic submissions creates an information lag of months. APIX enables "algorithmic" exchange, where data flows seamlessly between systems, allowing for automated validation, real-time assessment, and "sub-second" synchronization of product information.

2. The "ISO 20022" of Healthcare

Just as ISO 20022 harmonized the global financial sector to allow real-time, cross-border payments, APIX serves as the universal language for medicinal product exchange. By providing a single, structured standard that works across all borders and regulatory domains, APIX eliminates technical silos and creates a frictionless global market for medicines.

Global Submission Models

APIX is architecture-agnostic, supporting both centralized and decentralized exchange models. This ensures that regions can implement the system that best fits their national or regional infrastructure.

Centralized vs. Decentralized Exchange

Background: Solving the Fragmentation Crisis

The exchange of medicinal product information today is defined by extreme fragmentation.

  • Product Silos: Different formats and portals are required for human drugs vs. veterinary drugs vs. medical devices.
  • Procedure Silos: Clinical trial applications, marketing authorizations, and post-approval changes often use entirely different communication channels.
  • Information Lag: Because information is trapped in documents (portals, email, letters), regulators and industry are often "flying blind" regarding the real-time status of their applications.

APIX solves this crisis by providing a single, harmonized, API-first layer. It aligns regulatory exchange with the same modern technologies used in international banking and eCommerce—ensuring that life-saving medicines move through the regulatory pipeline as fast as the data that defines them.

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)

Governance & Collaboration

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

Get Involved

  • Join the weekly calls.
  • Test the reference implementation.

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