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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IG Home

Official URL: http://hl7.org/fhir/uv/recon-ig/ImplementationGuide/hl7.fhir.uv.recon-ig Version: 0.1.0
Draft as of 2025-11-14 Computable Name: ReconIG

Introduction

APIX is an HL7 FHIR R5 Implementation Guide that specifies a standardized, API-driven approach for the exchange of structured medicinal product information between regulators, marketing authorization holders, healthcare systems, and other stakeholders. It enables real-time, automated, and interoperable sharing of pharmaceutical quality data, electronic product information (ePI), pharmacovigilance information, and related regulatory data using modern FHIR-based patterns.

Background & Objectives

Inspired by the Uppsala Monitoring Centre's (UMC) IDMP Request and Publish API IG and the finance industry's real-time algorithmic systems Anderson, Algorri, Abernathy 2023, APIX leverages HL7 FHIR and modern API-based technologies to deliver automated, interoperable, and scalable data exchange for regulatory content.

APIX addresses the need for a modern, web-based framework for exchanging and processing regulatory content. It will deliver benefits that include:

  • Global interoperability between regulatory authorities, industry, and healthcare institutions
  • Rapid implementation by leveraging widely adopted web and FHIR standards
  • Dramatically improved speed and efficiency through automation, reducing administrative burden and processing times from months to minutes or seconds
  • Scalability to handle increasing submission volumes and data complexity without proportional resource growth
  • Higher data quality via built-in real-time validation and structured formats
  • Innovation enablement by using open web standards and platforms that encourage new tools, services, and ecosystem participation

In-Scope

APIX defines a standardized, FHIR and API-first framework for exchanging regulatory content across the regulated product lifecycle, including:

  • Clinical Trial Applications (IND/CTA/IMPD)
  • Marketing Authorization Applications (NDA/MAA/NDS etc.)
  • Post-Approval Changes and lifecycle management (variations, supplements, annual reports)
  • Adverse Event and Individual Case Safety Reports (ICSR)
  • Health Authority questions, responses, and information requests
  • Labeling negotiation and electronic Product Information (ePI) dissemination
  • Health Technology Assessment (HTA) submissions and evidence packages
  • Pharmacovigilance signal management and risk management plans
  • Regulatory establishment and inspection submissions (GMP, GCP, GLP facilities, audits, and compliance data)

Out of Scope

Global identifier resolution and master data synchronization (PhPID, GSID, substance and organization identifiers) are explicitly out of scope for APIX. These aspects are fully addressed by the UMC IDMP Request and Publish API Implementation Guide.