The ISO standards for Identification of Medicinal Products (IDMP) provide an internationally accepted framework to uniquely identify and describe medicinal products. Driven by regulatory requirements, the role of IDMP is to align the pharmaceutical industry on data standards for product and substance information. Realization of the full potential of IDMP depends on self-describing data to counteract diverse, non-standard IDMP implementations.

For this purpose, we will augment the existing IDMP standardization efforts with an IDMP Ontology that enables deep, semantic interoperability based on FAIR principles. This will ultimately enable entirely new ways of collaboration and enable early adopters to gain a competitive advantage in innovation, drug safety and overall operational efficiency. The IDMP Ontology (IDMP-O) effort extends the ISO standards as a digital standard to create interoperability by design. The intent is to submit the resulting ontology, once complete, either to the ISO directly or via the ISO PAS process through the Object Management Group.

The scope of this project includes the following ISO standards:

1. ISO-11238 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances
2. ISO-11239 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units ofpresentation, routes of administration and packaging
3. ISO-11240 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement
4. ISO-11615 - Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
5. ISO-11616 - Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
6. ISO-21090 - Health informatics — Harmonized data types for information interchange

The final deliverable will provide a solution agnotistic technology for the data fabric system across various environments that handle the biomedical data.

More information about the development of this ontology can be found on our wiki and on the Pistoia Alliance website.