Despite the ISO IDMP standards, the same medicine is often described differently. This article explains the IDMP Ontology, how it aligns product data across systems and organizations, and how to get access.
This article is based on the IDMP Ontology Community of Interest webinar hosted by the Pistoia Alliance on 1 July 2026.
Regulators are asking the pharmaceutical industry to describe its products in one common, standardized way. The ISO IDMP standards define what information to capture. However, not everyone interprets these standards the same way, so two companies can follow the same rules and still describe the same medicine differently. Closing that gap is what the IDMP Ontology was built to do.
Here’s what it is, how it works, and how to get it.
What this article is about
This is an introduction to the IDMP Ontology from the IDMP Ontology team at the Pistoia Alliance, written for anyone who has come across the term but never had it explained plainly.
We cover what an ontology actually is, what the IDMP Ontology is and how it works, using the alignment of company data with the EMA’s Product Management Service (PMS) as a worked example. We explain why it was built collectively rather than by any single enterprise, where the project is heading, and how you can get access to it.
Who should read this
This article is for anyone who works with medicinal product data: regulatory affairs and regulatory information management professionals, master data and data governance owners, IT and data architects, standards and ontology specialists, and regulators themselves.
If you have heard of ISO IDMP, EMA PMS, or the IDMP Ontology and want to understand what they actually mean in practice and what to do about them, this article is for you.
The IDMP Ontology Explained: One Shared Language for Medicinal Product Data
A standard everyone reads differently
the ISO IDMP standards (ISO 11238, 11239, 11240, 11615 and 11616) are a set of five international standards that set out the information needed to identify a medicine precisely: its substances, dose forms, units of measurement, packaging and the product itself. As authorities like the European Medicines Agency (EMA) roll these out, companies must submit and maintain their product data in this standardized structure. The catch: the standards specify what information to exchange and how that information is interconnected, but there is room for interpretation. Left to fill in the details themselves, organisations implement the standards differently. As a result, data ends up in silos: hard to join up inside a company, and harder still to reconcile with regulatory agencies.
What is the IDMP Ontology?
Let’s start with the word. An ontology is simply an agreed set of terms and the relationships between them written down so that people and computers can use them. A plain dictionary tells you what a word means on its own; an ontology also captures how things connect. Things like, which substance sits inside which product, which pack size comes in which packaging. So, the meaning emerges from the whole rather than single terms.
The IDMP Ontology applies that idea to medicinal product data. It is an open, vendor-neutral, machine-readable model of the ISO IDMP standards. Every concept in the ontology carries one precise, ISO-referenced definition, plus the relationships that link them. Alongside HL7 FHIR, the widely used standard for exchanging health data between computer systems, it forms the implementation layer for ISO IDMP standards. It is a practical bridge between a standard written on paper and real data moving between real systems. And because the data structure is machine-readable, software, and increasingly AI agents, inherit meaning and context directly from the framework.
One example of how it works: aligning your data with the EMA
Take the EMA Product Management System (PMS) as a use case. Your product data lives in two places: you have data in your internal system and in the EMA’s PMS. Keeping those aligned as they drift apart over time is time and cost consuming. But if you tag both data sets to the same IDMP concepts as defined by the IDMP standards, the records can be lined up product record to product record, property entry to property entry. Then, differences that were previously invisible surface immediately. You can realign them and keep the two data sites in sync. That tagging is based on the shared understanding and digital language of the IDMP Ontology, allowing you to describe medicinal products consistently across systems, organizations, and borders.
And the EMA’s implementation of the PMS is only the start. Other regulators are moving in the same direction. Map once to a shared language like the IDMP Ontology, and each new authority becomes a configuration on that framework rather than a new project.
The value also doesn’t stop at compliance
The same backbone makes medicinal product data interoperable and reusable across regulatory, manufacturing, pharmacovigilance, supply chain and all other functions within an enterprise, turning a regulatory obligation into an AI-ready enterprise data asset.
A collective solution. An aligned industry.
The IDMP Ontology isn’t any one company’s tool. It grew out of pioneering ontology work in 2020 and launched as a pre-competitive Pistoia Alliance initiative after a workshop in late 2021. The team delivered its first working model in 2022, and Version 1.0 of the ontology followed in January 2024 under an open-source MIT licence, covering key concepts across all five ISO IDMP standards.
The ontology has been funded and further developed by a broad group of pharmaceutical companies, including Bayer, Novartis, GSK, Roche, Merck KGaA, Boehringer Ingelheim, Johnson & Johnson, AstraZeneca, Amgen, AbbVie, MSD and Pfizer, in collaboration with partners like ACCURIDS and the EDM Council. In 2024, it was recognized with the Bio-IT World Innovative Practice Award.
That collective authorship is the whole point. The consistent, trusted medicinal product data enabled by the IDMP Ontology can only be a benefit to one, if it built and shared by all.
The road ahead
The IDMP Ontology has now entered a long-term maintenance phase, with a multi-year commitment to keep the ontology current with the ISO standards, resolve issues, and make it simpler to adopt. A quarterly Community of Interest and regular user-group meetings keep the community learning from each other’s real-world implementations and the ontology aligned with industry demands.
How to get access and involved
The IDMP Ontology is open source. The public version is freely available to download from the ontology webpage. Updated versions are examined by Pistoia Alliance members (ontology funders and wider community) prior to public release.
If you’d like access to the IDMP Ontology, have questions about how to start, or want to see how others are using it, we’re glad to help. Reach out to idmpo(at)pistoiaalliance.org.
We also welcome everyone to join our Community of Interest.
If your organization is already a member of the Pistoia Alliance, we invite you to get involved. If not, this is an opportunity to explore how the Alliance supports pre-competitive collaboration across data, AI, interoperability, and standards.
We began this work with a simple end goal: better, more trustworthy medicinal product data — and, ultimately, patient safety. That’s not something any single company can achieve alone. Which is exactly why we encourage you to join us.
What can you do with this?
If you work with medicinal product data day to day, start by looking at where your product information requires manual effort to enter, update, reconcile. Think of ways that would optimize your data workflows, bearing in mind interoperability and automation.
If you work with regulatory data, consider the IDMP Ontology as shared infrastructure rather than a compliance cost. Mapping once to a common, ISO-referenced language positions your organization to align medicinal product data and build AI applications. If you would like to talk through where to start, we are glad to help.
Where to learn more
Browse the IDMP Ontology webpage for updates, resources, and events.
Join the Pistoia Alliance. Learn about benefits to members here.
About the authors
This article reflects the collective expertise of the IDMP Ontology team and community within the Pistoia Alliance. Final editorial work by Aditya Tyagi.
Many thanks to the speakers at our July 2026 Community of Interest webinar, Sheila Elz (Boehringer Ingelheim), Heiner Oberkampf (ACCURIDS) and Raphael Sergent (ACCURIDS), and to our Steering Committee and funding members, for their contributions, ideas, and continued support.
Join the conversation
- How far apart are your internal product data and the data your regulators hold — and what does it cost you to keep them aligned?
- What has held your organization back from adopting a shared standard like the IDMP Ontology?
- Share your perspective in the comments and connect with others working to make medicinal product data consistent, trusted, and reusable!
#IDMP #IDMPOntology #PharmaData #RegulatoryAffairs #Interoperability #FAIRData #Ontology #DataStandards #AIReadyData #PreCompetitiveCollaboration #PistoiaAlliance