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The European Medicines Agency (EMA) is in the process of implementing the standards
developed by the International Organization for Standardization (ISO) for the identification
of medicinal products (IDMP)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 and . As such, there is a need for a metadata-driven ontological solution to enhance
interoperability and connectivity across regulatory jurisdictions and . This will facilitate the
implementation of the ISO IDMP logical model.
The groups who potentially benefit from the IDMP Common Core Ontology are the
pharmaceutical industry, health authoritiesregulatory agencies, healthcare providers, and ultimately, patients.
References:-
https://www.ema.europa.eu/en/documents/other/introduction-iso-identification-
medicinal-products-spor-programme_en.pdfhttps://www.hl7.org/documentcenter/public/wg/medication/ISO IDMP -
%20Logical%20model%20classification%20and%20identification%20of%20pharmaceutical%
20and%20medicinal%20products.pdfCompanies that have expressed interest in this project include: Bayer, Bristol Myers Squibb, Ipsen, Merck, Novartis, Pierre-Fabre, Roche, Sanofi, Servier, US Pharmacopeia.