IDMP – O

The Challenge – Why is this important?

The European Medicines Agency (EMA) will be the first health agency to mandate compliance with ISO IDMP (Q4, 2024), with the FDA not far behind. Governance of essential IDMP standards and implementations is not assigned to a specific, overarching governing body. Diverging implementations of IDMP across geographical regions and jurisdictional domains are already causing inconsistencies in the interpretation across implementing organizations. Given that there is no semantic alignment between regulatory bodies, there exists a risk that regulatory compliance needs will lead to large integration and interoperability costs and that the benefits from IDMP in drug safety, innovation, and other areas will not be fully realized. Rather than concentrating on the discovery of new medicines, organizations will be struggling with data issues, e.g., the need to map product data across the organization, throughout the product lifecycle.

What does the project achieve?

The Pistoia Alliance was selected to manage this initiative with the goal of creating an ontology that demonstrates added value to the ISO IDMP standards for data usability across organizational boundaries and regulatory jurisdictions. We have pulled together a project team consisting of Pharmaceutical stakeholders, regulatory bodies, standards organizations, non-profit groups, and solutions providers for this project.

The key objectives for the project include:

• Provide a digital, machine-processable standard.
  – The Pdf document provided by EMA is not enough as different groups implement it differently
• Solve ambiguities of the ISO IDMP standards enabling feed improvements back to ISO through systematic reviews
• Bridge different views with ONE product data model between internal pharma departments and between industry groups
• Provide a vendor-agnostic, and open-source model. The ontology is fully standards-based without any proprietary aspects
• Reduce implementation effort through a common goal

The latest public release V1.2 is available here, under the MIT open source license. To browse the public release version of the ontology in OntoViewer, click here. If you would like to report a bug in the ontology, please write to idmpo@PistoiaAlliance.org.

Find out more at the following links:

• If you are a Pistoia Alliance Member, you can request free access to download or browse V1.3 and V1.4 via OntoViewer. To request user access please contact idmpo@PistoiaAlliance.org.
• Funding members of the project have access to the latest releases via a private GitHub repository. If you are funding member and are unable to access it, please contact idmpo@PistoiaAlliance.org.
• Description and details of all ontologies until V1.4 are available here.
• A demo instance with public data aligned to the IDMP Ontology is available here.

IDMP-O Official Partners