Navigating the future of medicinal product data exchange: understanding XEVMPD and its crucial role in regulatory compliance

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This article focuses on the current process followed for eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) submissions and its future transition to ISO IDMP standards. The comprehensive data retained within XEVMPD not only facilitates compliance with regulatory requirements but also acts as a basis in bolstering pharmacovigilance strategies. From data submission to the real-world applications in monitoring adverse drug reactions, this exploration seeks to provide a comprehensive overview of the symbiotic relationship between XEVMPD data and pharmacovigilance endeavors within the European Union (EU) and European Economic Area (EEA).

Although XEVMPD is critical to manage regulatory and pharmacovigilance activities and the data generated through XEVMPD is maintained in accordance with European standards currently, there is still a persistent need for global standardisation in the effective exchange of medicinal product information. To harmonise the identification and exchange of medicinal product information further, the European Medicines Agency (EMA) is adopting the International Organization for Standardization’s (ISO) identification and description of medicinal products (IDMP) for data creation and storage. This article provides insights on the benefits of IDMP standards and their implication in navigating medicinal product data exchange.

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