The global not-for-profit alliance advocates for ‘greater collaboration in life sciences research and development and now plans to support the implementation of IDMP-O across the pharmaceutical sector. It is now calling for pharma, technology companies, health authorities, and regulators to register interest in dedicated training programs on integrating IDMP-O into workflows.
The ontology is already in active implementation at several companies and was co-developed under the alliance umbrella by 11 organizations: Bayer, Novartis, GSK, Roche, Merck KGaA, Boehringer Ingelheim, Johnson & Johnson, AstraZeneca, Amgen, AbbVie, and Pfizer. Contributing project partners also include the EDM Council, ACCURIDS, OSTHUS, and Chemantics.
Created by the alliance, it says the common semantic data model will realize the intended benefits of IDMP standardization, including improved pharmacovigilance, enabling cross-border prescriptions, and preventing medication shortages through interoperability with manufacturers.
The ontology will complement existing IDMP standards set by the ISO and ensure all IDMP data is machine-readable from the point of its creation to better support the use of AI technologies across the industry.
The ISO 9000 family is a set of five quality management systems standards by the International Organization for Standardization that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service.
Bridging pharma, manufacturem regulator gap
“IDMP-O is one of the Pistoia Alliance’s flagship projects with nearly a dozen of our large member companies involved. Our ontology bridges the gap between regulators, pharma, manufacturers, and the clinical space by offering a powerful common language for the description of medicinal product information,” says Becky Upton, president of the Pistoia Alliance.
“With IDMP-O, organizations can more easily comply with standards set by organizations like ISO, reduce duplicated efforts, and ensure patients are prescribed the correct medication for their needs. This project’s success has been made possible by the Alliance’s legal framework for pre-competitive collaboration and underlines the value of the alliance to the life sciences sector.”
The alliance explains that IDMP standards are critical for giving healthcare providers and manufacturers trusted information about medicinal products regardless of brand names. Standardizing data on substances and drug marketing (Packaged Medicinal Product Identification) ensures medications are made to the correct specification and enables healthcare providers to prescribe safe alternatives if one brand becomes unavailable more easily.
For example, it says, a key use case is cross-border prescriptions; IDMP standards make it possible to compare drug information across different countries’ medicinal product dictionaries. This means a patient in Belgium can be sure they’re taking an equivalent drug to one they were prescribed in Germany.
Heiner Oberkampf, CEO and co-founder of Accurids, said: “We’re excited to be supporting the creation of a robust data backbone that will help organizations to automate IDMP data management and ensure their data is FAIR (Findable, Accessible, Interoperable, Reusable).
Complex IDMP standards
“Implementation of IDMP standards is complex, with a large volume and variety of medicinal data to process held by pharma companies, drug manufacturers, and regulators. But with IDMP-O, organizations can reduce the risk of errors and ensure their data is interoperable and AI-ready to get the most out of it.”
The Alliance’s Open Source IDMP Ontology is now freely available via PA’s ontology governance infrastructure provided by EDM Council and ACCURIDS. Alongside the next phase of the project, governance will be further secured by ISO Technical Specification (TS) 21405, an official methodology and framework for the development and representation of IDMP Ontology.
This is co-led by project champions Sheila Elz of Bayer, and Vada Perkins of Boehringer-Ingelheim, with a publication expected in July 2025.
Organizations are invited to get in touch to find out more about the opportunities to support the next stage of the project and explore workshops to help implement IDMP-O into their systems.
