The latest release strengthens regulatory compliance capabilities and deepens integration with the wider life sciences data ecosystem.
The Pistoia Alliance has released version 1.6 of the IDMP Ontology (IDMP-O), an expert-built framework for implementing the IDMP ISO standards.
IDMP-O provides the industry with a shared, machine-readable language for medicinal product data that goes beyond the legal requirements of the ISO standards and gives organizations a framework for internal data alignment, regulatory submission, and cross-system interoperability. Version 1.6 is now available to funding project members and will be made available to all Pistoia Alliance members in six months. Version 1.4 remains publicly available.
A stronger foundation for regulatory and enterprise use
Version 1.6 delivers a number of significant improvements that make the ontology more robust, more interoperable, and easier to implement across the industry.
The release strengthens support for the batch tracking use case, improving the ontology’s ability to represent the full lifecycle of medicinal product batches. This capability is of growing importance as regulators and industry alike move toward end-to-end traceability.
Critically, v1.6 deepens IDMP-O’s integration with the broader life sciences data ecosystem. The ontology now aligns with the Basic Formal Ontology (BFO), the Financial Industry Business Ontology (FIBO), the Industrial Ontology Foundry (IOF), and the Pistoia Alliance’s own CMC Process Ontology. Thus, organizations working across multiple data standards and domains can achieve true semantic interoperability. The release also includes improved vocabularies and metadata, the resolution of a number of reasoning and consistency challenges, and targeted bug fixes throughout.
On the relevance of this release, Project Manager Aditya Tyagi shares: “this release is the product of sustained collaboration between pharmaceutical companies, ontology experts, and industry partners who understand that consistent, trusted medicinal product data is not a competitive issue, but a shared infrastructure challenge. IDMP-O gives the industry a single, authoritative language for IDMP data that organizations can implement with confidence. Version 1.6 makes that language richer, more interoperable, and more ready for the demands of the next decade.”
Invitation to explore the IDMP Ontology
The Pistoia Alliance invites pharmaceutical companies, technology vendors, and regulatory data experts to engage with the ontology, whether as funding members with immediate access to the latest versions or as part of the IDMP-O Community of Interest.
Find out more about the IDMP Ontology and access to members on the project webpage.
The public version of the IDMP Ontology can be accessed here.
For information on membership and funding, visit pistoiaalliance.org/membership.