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

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Official URL: http://hl7.org/fhir/uv/apix/ImplementationGuide/hl7.fhir.uv.apix Version: 0.1.0
IG Standards status: Trial-use Maturity Level: 1 Computable Name: ApixIG

HL7 FHIR R5 · Global Standard

Regulatory exchange,
reimagined.

The global common language of regulatory communications.

Side-by-side comparison: today's fragmented regulatory exchange — many pathways (eCTD, non-eCTD, email, secure email, AS2 gateway, FTP, paper, regular mail) with product-type and procedure-type silos that are unidirectional, inconsistent, outdated, and costly — versus APIX: one open-source, platform- and vendor-agnostic standard supporting 1:1 exchange of structured and unstructured content (PDF, DOCX, XML, JSON, datasets) for all product types, all procedure types, all regulators, and all companies. Like SWIFT / ISO 20022 for finance, but for regulatory information.

How It Works

Five steps to connect your systems to a regulator — that's it.

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Step 1
Connect

Register your company via API

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Step 2
Stream

Upload files (PDF, XML, JSON, data sets) as FHIR Binary resources

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Step 3
Describe

Create DocumentReference metadata for each file

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Step 4
Orchestrate

Create a Task to initiate and track any regulatory activity

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Step 5
Subscribe

Get real-time notifications as activities progress

Why adopt APIX

Replace fragmented portals, emails, and static documents with a single, modern API standard.

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One Universal Interface

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.

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Built on Web Standards

Same RESTful APIs and OAuth2 that already run global banking, eCommerce, and modern healthcare (SMART on FHIR). Zero proprietary formats.

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From Months to Seconds

Submissions, questions, and decisions become real-time events. Cycle-time delays become visible and instantly actionable.

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Instant Analytics

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

About APIX

The exchange of medicinal product information today is defined by extreme fragmentation: different formats and portals for human drugs vs. veterinary drugs vs. medical devices; entirely different communication channels for clinical trial applications, marketing authorizations, and post-approval changes; and information trapped in documents that leaves regulators and industry "flying blind."

APIX solves this crisis by providing a single, harmonized, API-first layer — aligning 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.

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Governance & Collaboration

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

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Get Involved

Join the weekly calls. Test the reference implementation. We welcome industry, solution providers, and regulators from every region to contribute.

Scope

✅ In Scope
  • Human medicinal products
  • Medical Devices
  • Veterinary products
  • Over-the-Counter (OTC) products
  • Natural Health Products (NHP)
  • Clinical trials & Master files
  • Regulatory submissions & procedural management (variations, supplements, Q&A)
  • Adverse Event Reporting (ICSRs)
  • Payment of application fees
  • Health Technology Assessment (HTA) dossiers
  • Establishment & inspection submissions

FHIR Resources

The following HL7 FHIR resources form the core of the APIX standard.