The implementation of IDMP through the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) is reshaping regulatory data management in Europe. MAHs must ensure timely submission and ongoing updates of product data, transitioning from XEVPRM to ISO IDMP and HL7 FHIR formats. EMA’s phased SPOR framework—covering Substance, Product, Organization, and Referential data—enables harmonized, high-quality master data across the product lifecycle. Challenges include cross-functional alignment, data governance, and system integration, requiring new processes, upgraded technology, and enriched reporting. Strategic partnerships, such as IQVIA’s work with Sobi, show how proactive planning ensures compliance and digital readiness.

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