The Pistoia Alliance has completed the first phase of its Identification of Medicinal Product (IDMP) Common Core Ontology project. This ontology would support enterprises in complying with the upcoming implementation by the European Medicines Agency (EMA) of the five IDMP standards set by the International Organization for Standardization (ISO).
Currently, there is no overarching body for the governance of IDMP standards. This means the terminology to describe substances used in the regulatory, supply chain, pharmacovigilance, and clinical sectors are inconsistent. There is a risk that when the new EMA implementation becomes mandatory, enterprises will suffer increased costs associated with manual tasks to keep up with compliance and interoperability issues.
The freely available ontology in development at the Alliance will mean the drug data involved in the R&D processes can be created, stored, and translated to an IDMP-compliant machine-readable format automatically so that researchers can refocus on innovation and the discovery of new medicines.
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