This is an article from the Pistoia Alliance IDMP Ontology community.
The ISO IDMP standards specify what medicinal product data should include, but they cannot eliminate differences in regional regulatory requirements or organizational perspectives. As organizations began implementing the standards, there was a growing need for a common semantic framework that could connect these perspectives and support more consistent data exchange.
The obvious fix was for the whole industry to build one shared model together with regulators instead of a dozen diverging ones. The hard part was doing that between competitors, in the open, without anyone owning it. This is the story of how that happened, from an informal conversation outside a conference in 2021 to an open, industry-owned ontology in production today.
What this article is about
A short history of the Pistoia Alliance IDMP Ontology (IDMP-O): where the idea came from, how it became a pre-competitive Pistoia Alliance initiative, and how it grew from a first proof of concept into a shared industry asset for pharma. It’s the origin story behind a piece of shared infrastructure many teams now rely on.
Who should read this article
- Regulatory, data standards and semantic technology teams in pharma weighing up ISO IDMP implementation.
- Data and IT leaders who want to understand where the IDMP Ontology came from before adopting it.
- Anyone curious about how pre-competitive collaboration works; how competitors build shared infrastructure once, and together, rather than repeatedly in isolation.
If you’ve ever wondered why the industry chose to solve the IDMP data problem collectively, this is for you.
A shared foundation
Every so often, a shared foundation emerges not because one company decides to build it, but because an industry recognizes a common challenge and comes together to solve it. The IDMP Ontology is one such example. Here is how it came together.
The problem IDMP-O set out to solve
As global regulatory authorities, including the European Medicines Agency (EMA), progressed their adoption of the ISO standards for the Identification of Medicinal Products (IDMP), it became increasingly evident that organizations were implementing these standards differently according to varying requirements and perspectives. While the standards define the medicinal product information that needs to be documented, they do not provide a common semantic framework to support consistent understanding across organizations, systems, and jurisdictions. Consequently, differing implementations driven by regional requirements and organization perspectives can create challenges for data integration, interoperability, and information exchange throughout the pharmaceutical value chain.
Today, the IDMP Ontology is an industry-led initiative under the Pistoia Alliance that solves those pressing challenges and enables product data interoperability.
From early experiments to a formal initiative
The origins of the IDMP Ontology can be traced back to 2021. Representing a group of data and semantics experts from Roche, Bayer, GSK, ACCURIDS, Novartis, and Merck KGaA, Sheila Elz, Heiner Oberkampf, and Gerhard Noelken proposed to the Pistoia Alliance the creation of a shared, vendor-neutral semantic foundation for medicinal product data.
Following a collaborative workshop, the project was formally launched as a pre-competitive initiative. Its mission was to develop an open-source, machine-readable semantic model that would complement existing IDMP standards, reduce implementation ambiguity, and enable FAIR (Findable, Accessible, Interoperable, and Reusable) data across regulatory, clinical, manufacturing, supply chain, and pharmacovigilance domains.
Proof, then momentum
Phase 1 of the project commenced in 2022 with sponsorship from seven leading pharmaceutical companies. Within the same year, the team successfully delivered its first Minimum Viable Product (MVP), focused on substance-related use cases. The ontology was validated using real-world industry data and demonstrated the value of semantic interoperability for medicinal product information management.
Building on this success, the project rapidly expanded to include additional pharmaceutical companies, technology providers, standards organizations, and regulatory stakeholders. Participants and sponsors have included Bayer, Novartis, GSK, Roche, Merck KGaA, Boehringer Ingelheim, Johnson & Johnson, AstraZeneca, Amgen, AbbVie, MSD, and Pfizer, alongside strategic partners such as the EDM Council (now EDM Association), CrownPoint Technologies, and ACCURIDS.
In parallel with the growth of the ontology, the project helped catalyze broader industry standardization efforts. In 2023, use cases and lessons learned in the IDMP Ontology project were included in the ISO Technical Specification (TS) 21405. This guidance for the representation, governance, and implementation of IDMP standards using IDMP ontology was published in March 2026.
A shared industry asset
A major milestone was achieved in January 2024 with the release of Version 1.0 of the ontology under an open-source MIT license. Covering key concepts across all five ISO IDMP standards, Version 1.0 marked the transition from pilot development to production implementation and established the IDMP Ontology as a shared industry asset supporting regulatory compliance, data governance, interoperability, and digital transformation initiatives.
The impact of the project was further recognized in 2024 when the IDMP Ontology received the Bio-IT World Innovative Practice Award, acknowledging its successful application and demonstrated value across multiple organizations.
Since then, the IDMP Ontology has continued to evolve through regular community-driven releases, expanding support for regulatory reporting, jurisdiction-specific vocabularies, manufacturing and supply chain data, batch traceability, and enterprise product master data management.
Today, the IDMP Ontology, together with HL7 FHIR messages, serves as a foundational implementation layer for ISO IDMP. As an open-source, vendor-neutral semantic framework, it enables consistent medicinal product data representation, cross-system interoperability, regulatory compliance, and AI-ready data ecosystems. Guided by an active Steering Committee and supported by a growing global community, the IDMP Ontology initiative continues to advance toward the vision of a shared digital language for medicinal product information across the healthcare and life sciences industries.
What can you do with this?
If you’re a practitioner in regulatory data, semantic technologies, ontology engineering, or IT, the IDMP Ontology gives you an open, machine-readable starting point for ISO IDMP implementation instead of a blank page. It is a shared industry reference model you can use to resolve internal definitional inconsistencies, map and integrate your data, and build a semantic foundation. It’s free to browse, download, and evaluate.
If you’re a leader in data strategy, R&D IT, or Regulatory Operations, the story here is not just about IDMP, but about building for the future. Adopting a shared, vendor-neutral model allows organizations to benefit from collective industry expertise while avoiding the cost of repeatedly solving the same integration challenges. Beyond supporting compliance and interoperability today, it creates the high-quality, standardized data foundation needed for tomorrow’s AI-enabled capabilities.
Join the IDMP-O community
The IDMP Ontology is built and maintained by its community. Whether you’re already implementing ISO IDMP or just starting to explore it, there’s a place for you: browse and download the ontology, join a Community of Interest webinar, or get involved with the group of people actively implementing the ontology and learning from each other’s experiences.
Consistent medicinal product data isn’t a competitive advantage to hoard. It’s a shared infrastructure that benefits the whole industry, built once, built together.
Where to learn more
- The IDMP Ontology webpage
- Browse the ontology
- Access the public release on GitHub
- Watch the latest Community of Interest webinar
- Join the Pistoia Alliance
About the authors
This history reflects the collective work of the members of the IDMP Ontology group at the Pistoia Alliance and the Steering Committee guiding the evolution of the IDMP Ontology today.
Written by Aditya Tyagi (Pistoia Alliance), Heiner Oberkampf (ACCURIDS), Sheila Elz (Boehringer Ingelheim) and Christian Baber (Pistoia Alliance)
With special thanks to the participants, founders, and colleagues from Bayer, GSK, Merck KGaA, MSD, Novartis, Roche, Johnson & Johnson, Boehringer Ingelheim, Pfizer, AstraZeneca, AbbVie, Amgen, ACCURIDS, and EDMA.
Join the conversation
A question we’d like your take on:
If your organization has implemented ISO IDMP standards, what was the hardest part and would a shared semantic model have changed it?
Connect with the IDMP Ontology team and share your thoughts.