IDMP – Ontology

The Challenge – Why is this important?

Regulatory requirements for pharmaceutical data are tightening globally. The European Shortage Monitoring System has been in effect since 2025, and the EMA’s Product Management System is being established as the single authoritative, ISO IDMP-compliant record for all authorized medicines in Europe. Finally, regulatory alignment is accelerating across other jurisdictions worldwide. 

 The IDMP ISO standards define what information pharmaceutical companies must record about their medicinal products in machine-readable form. But legal standards alone leave room for interpretation. Without a shared implementation framework, the same medicine can be described in subtly incompatible ways across systems, for example between regulatory, manufacturing, and clinical supply divisions. The result is data fragmentation that drives up integration costs, surfaces data quality issues across sources, slows regulatory processes, and limits the potential of AI-driven innovation. 

 The IDMP Ontology solves that problem. Rather than each organization interpreting the standards independently, the ontology provides the shared digital language that makes medicinal product data consistent, connected, and interoperable across the pharmaceutical value chain. 

What does the IDMP Ontology deliver?

The IDMP Ontology builds out the ISO standards with a semantic framework that resolves ambiguities in the standards, bridges different data views across internal departments and functions, and provides a vendor-agnostic data model that any organization can adopt and build upon. Pharmaceutical companies have deployed the ontology for enterprise-wide product master management, regulatory submission workflows, internal data integration, data quality monitoring, and as a backbone for AI-ready data infrastructure.  

As of May 2026, maintenance of the ontology is secured through a three-year engineering partnership with Accurids, guaranteeing quarterly releases and continuous technical improvements. The vision is to ensure long-term sustainability via regular adaptation and renewal of the partnership.  

 Additionally, the ontology’s active Steering Committee, comprising leading experts from leading pharmaceutical organizations, shapes its technical direction and strategic enhancement priorities to reflect real implementation needs across the industry. The Steering Committee is committed to reducing ontology complexity, building a simplified core ontology, and creating ready-to-deploy use cases that ease implementation. The delivery of corollary assets like vocabularies, knowledge graphs, and implementation guides also lower the barrier to entry for organizations at any stage of their IDMP journey.

Access the IDMP Ontology

The latest public release, V1.4, is available here under the MIT open-source license. To browse the public release: 

• Register at https://pistoiaalliance.accurids.com 

• Start your search for concepts at https://pistoiaalliance.accurids.com/goto/xFePYCja0h

To report a bug, write to idmpo@PistoiaAlliance.org. 

Funding project members have immediate access to V1.5 and V1.6 via a private GitHub repository. If you are a funding member and are unable to access it, please contact idmpo@PistoiaAlliance.org. 

Pistoia Alliance members have access to V1.5 and will receive access to V1.6 within six months of release. Find out more about Pistoia Alliance membership or contact idmpo@PistoiaAlliance.org for access. 

A demo instance with public data aligned to the IDMP Ontology is available here. 

IDMP Ontology Training Modules are available free of charge to funding project members. Write to idmpo@PistoiaAlliance.org for access. Training recordings are also available for purchase here. 

IDMP Ontology Official Partners