The European Medicines Agency is in the process of implementing ISO identification of medicinal product (IDMP) standards, and the US Food and Drug Administration (FDA) is not far behind. To meet the requirements, pharmaceutical companies will need to have IDMP-compliant systems, data assets, and business processes.
The objective of IDMP is to create a universal framework of structured, coded data; however, diverging implementations of IDMP across different jurisdictions have created inconsistencies and lack of alignment between regulators, as well as within industry. Without an overarching body for IDMP governance standards, terminology used to describe substances across the lifecycle is inconsistent and as a result, the aim of simplification and standardization is only partially achieved.
To address this issue, the Pistoia Alliance has created an IDMP Ontology to achieve transparency and data consistency in using the ISO IDMP standards. The IDMP Ontology does this by providing a universal implementation of the IDMP product data model as a common language, with the purpose of facilitating the connection between people, processes and systems.
The Pistoia Alliance is a non-profit alliance advocating for greater collaboration in life sciences R&D. It was incorporated in 2009 by representatives from AstraZeneca, GSK, Novartis and Pfizer and now has more than 100 member companies. The Alliance’s IDMP Ontology project brings together industry experts – including from large pharma companies – to support compliance with the IDMP by enabling data integration and automation of processes.
The first phase of the project has been completed, with the focus on the substance domain, establishing a set of collaboration principles and an effective governance framework. The use of the IDMP Ontology has been demonstrated against public data from the FDA’s Global Substance Registration System (GSRS) and examples from the EudraCT and the National Library of Medicine’s DailyMed, as well as from internal data from several pharmaceutical companies. The alliance has also submitted a proposal for IDMP Ontology to be referenced in the ISO Technical Specification.
Osthus, a PharmaLex company, is an implementation partner for ontology development as well as for specifying relevant IDMP ontology use cases and value capture.