Project Information
Active
21 October, 2026
Project Introduction
Regulatory Workflows and Interactions - pharma
The Regulatory Workflows and Interactions – pharma project aims to create an internationally harmonized, API-first framework for exchanging medicinal product information using FHIR standards. By replacing batch and document-based exchanges with modern APIs, Regulatory Workflows and Interactions – pharma enables real-time, two-way data exchange between regulators, biopharma companies, healthcare institutions, and other stakeholders.
This project will deliver an Implementation Guide (IG) that defines a unified framework for API-driven exchange, improving efficiency, interoperability, and regulatory collaboration worldwide.
Current Goals
- Draft the first version of the Regulatory Workflows and Interactions - pharma Implementation Guide.
- Align with related efforts such as ePI and IDMP PhPID.
- Develop and test sample data for demonstration and connectathon participation.
- Prepare for technical testing at connectathons starting in 2025.
Regulatory Workflows and Interactions - pharma
Project Resources
Project workspace with meeting notes, documentation, and collaboration materials.
Central repository for project artifacts, reference materials, and shared files.
Regulatory Workflows and Interactions - pharma
Get Involved
The Regulatory Workflows and Interactions – pharma project is open to new members and collaborators. As with all Vulcan projects, anyone can participate by:
- Joining weekly working group calls.
- Contributing expertise in regulatory, technical, or implementation areas.
- Piloting or testing draft specifications.
Vulcan is a member-based organization, but participation in projects is open to all. If you’re interested in shaping the future of real-time medicinal product exchange, this is the right time to join.
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