Regulatory Workflows and Interactions - pharma
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Regulatory Workflows and Interactions - pharma, 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.

Regulatory exchange is globally fragmented across authorities, product lines, procedures, and technologies. This IG establishes a common Task- and Subscription-based framework for regulatory workflows and interactions, enabling them to be exchanged, tracked, and acted upon with machine-readable status and event-driven notifications.

Before and after RWI-pharma. Before: industry connects to each regulator using different exchange methods — email, secure email, FTP, AS2, HTTPS, portals, and mail — that vary per product type, per procedure, and per country. After: industry uses one standardized FHIR API connection pattern (Task, DocumentReference, Binary, Subscription) with every regulator, regardless of product type, procedure, or country.

About this IG

The Regulatory Workflows and Interactions - pharma Implementation Guide defines how FHIR can support end-to-end digital regulatory workflows and interactions between applicants and regulatory authorities for human biopharmaceutical products.

Today, regulatory exchange is highly fragmented. Authorities may use different mechanisms across product lines and procedures, including portals, gateways, email, secure email, FTP, HTTPS, and physical mail. These differences multiply across regulators globally, creating significant complexity for industry and limiting interoperability.

Applicants also frequently lack end-to-end visibility into the status of their regulatory interactions. Consumers can track a FedEx or Amazon delivery through each major step and receive notifications as it progresses, yet applicants often cannot similarly track a critical regulatory interaction or receive automated notifications when key milestones occur.

Using Task, DocumentReference, Binary, Subscription, APIs, and related FHIR capabilities, the guide enables regulatory activities to be interoperable, traceable, trackable, and event-driven, replacing fragmented exchange mechanisms with a standardized digital workflow.

Scope

This Implementation Guide focuses on human biopharmaceutical products and the regulatory procedures and interactions associated with their development, authorization, and lifecycle management.

✅ In Scope

Regulatory procedures and interactions, including but not limited to:

  • Clinical trial regulatory interactions
  • Adverse event and safety-related interactions
  • Product information and label negotiation
  • Marketing authorization procedures
  • Regulatory requests and responses
  • Post-approval changes and lifecycle management
  • Other regulatory procedures involving interactions between applicants and regulatory authorities
⛔ Out of Scope (current phase)

The following product domains are out of scope for the current phase:

  • Medical devices
  • Veterinary drugs
  • Over-the-counter drugs
  • Natural health products
  • Food
  • Cosmetics
  • Inspections

These domains are out of scope for the current phase only. Subsequent phases of the project are expected to expand the scope to support regulatory workflows and interactions in these and other regulated-product domains.

How It Works

Five steps to connect any two parties, industry or regulator, in either direction.

🔌
Step 1
Connect

Register your organization via API

→
📤
Step 2
Stream

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

→
🏷️
Step 3
Describe

Create DocumentReference metadata for each file

→
📋
Step 4
Orchestrate

Create a Task to initiate and track any regulatory activity

→
🔔
Step 5
Subscribe

Get real-time notifications as activities progress

Why adopt RWI-pharma

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

🌐
One Universal Interface

One common FHIR framework for regulatory workflows and interactions across procedures and authorities — one connection at the agency reaches all companies; one connection at the company reaches all regulators.

Explore universal submissions →
📤
Submit via Web-Standard APIs

Post regulatory submissions directly via FHIR APIs, using the same RESTful APIs and OAuth2 that already run global banking, eCommerce, and modern healthcare (SMART on FHIR). Zero proprietary formats.

See the workflow →
📊
Track in Real Time

FedEx-style status tracking for every regulatory procedure. Submissions, questions, and decisions become real-time events — delays become visible and instantly actionable.

How notifications work →
📈
Instant Analytics

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

Task milestones →

Governance & Participation

🤝
Governance & Collaboration

RWI-pharma 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.