Ontologies for IDMP Implementation

Open

Project Idea: Build an IDMP Common Core Ontology

Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) obliges European Union (EU) Member States, marketing authorisation holders and EMA to make use of the ISO IDMP standards.

This will impact on many areas of the pharmaceutical regulatory environment, both in the EU and other regions.

EMA is implementing the standards in a phased programme based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) master data.

Their purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

Work is ongoing to determine an IDMP logical model to define an agnostic data architecture to facilitate implementation and automate connectivity. However, the model is not a FAIR representation. As such, there is a need for a metadata-driven ontological solution to enhance interoperability and connectivity across regulatory jurisdictions. This will facilitate the implementation of the ISO IDMP logical model.

The groups who benefit from the IDMP Common Core Ontology are the pharmaceutical industry, regulatory agencies, healthcare providers, and ultimately, patients.

Companies that have expressed interest in this project include: Bayer, Bristol Myers Squibb, Ipsen, Merck, Novartis, Pierre-Fabre, Roche, Sanofi, Servier, US Pharmacopeia.