The Pistoia Alliance has announced the next phase of its Identification of Medicinal Products Ontology (IDMP-O), aiming to help pharmaceutical companies prepare for tighter European medicines data requirements ahead of the European Medicines Agency’s June 2026 submission deadline.

The not-for-profit organisation said the updated governance model for IDMP-O will support more consistent implementation of ISO standards governing how medicinal product data is recorded and exchanged, helping regulators, manufacturers and healthcare providers use a shared digital framework for cross-border prescriptions, pharmacovigilance and medicines shortage monitoring.

The ontology is designed to provide a common way of describing medicinal products, pharmaceutical products, substances, dose forms, packaging and routes of administration. According to the Pistoia Alliance, more than 10 pharmaceutical companies have already adopted the framework.

The latest phase formalises long-term stewardship of the project, with Accurids responsible for expert maintenance while governance will be overseen by Pistoia Alliance members including Johnson & Johnson, Boehringer Ingelheim, Merck & Co., Amgen and Global Value Web.

The announcement comes as medicinal product manufacturers face a June 2026 deadline to submit standardised product data to the EMA’s Product Management System, either through the platform’s user interface or via API integration.

Dr Becky Upton, president of the Pistoia Alliance, said: “IDMP is the silent backbone of global drug data. It underpins how medicines are described and understood between organizations. Previously, there was too much room for interpretation, increasing the risk of inconsistencies across companies and markets. Through the Pistoia Alliance, members have created a shared ontology once, collaboratively, rather than repeatedly in isolation.”

She added: “More than 10 major pharmaceutical enterprises have adopted IDMP-O – a signal of how important shared semantic layers are in an era of tightening regulatory and accelerating AI adoption. We’re actively looking for more organizations to get involved as we ensure IDMP-O remains a stable, reliable and reference industry resource for years to come.”

The move reflects the industry’s gradual shift away from document-based regulatory submissions towards structured digital data that can be exchanged consistently across organisations and jurisdictions.

Gang Xue, senior director, global head of TDS digital at Johnson & Johnson, said: “Seeing our consortium’s work translated into action has been very rewarding. Working with Accurids to build an IDMP-O-based product master for our Innovation Medicine sector showed how a shared industry resource can move beyond theory and become practical enterprise data infrastructure.”

IDMP-O covers all five ISO Identification of Medicinal Products standards and is intended to create a common semantic structure for medicinal product information that can support regulatory submissions and downstream healthcare applications.

The alliance said the next development phase will focus on lowering technical barriers to adoption by providing simplified vocabularies, knowledge graphs and implementation guides for organisations at different stages of their IDMP programmes.

Heiner Oberkampf, chief executive officer and co-founder of Accurids, said: “Over the past 5 years, ACCURIDS has partnered with the Pistoia Alliance to create the IDMP Ontology and establish it in pharma. This 3-year commitment provides the maintenance required to move IDMP-O into broader adoption across the industry while ensuring seamless alignment with evolving ISO IDMP standards.”

A public version of IDMP-O is already available following phased development by industry members, with the Pistoia Alliance continuing to encourage broader participation as medicines data requirements evolve.