Adoption of Identification of Medicinal Products Standards in Europe: Health Authorities and Industry Insights

Jones Katrin ()
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Jones Katrin: Researcher at Department of Health Technologies, Tallinn University of Technology, Tallinn, Estonia

European Studies - The Review of European Law, Economics and Politics, 2024, vol. 11, issue 1, 274-299

Abstract: This article explores the adoption of the ISO Identification of Medicinal Products (IDMP) standards in Europe, aimed at establishing a unified framework for identifying medicinal products to enhance regulatory efficiency and patient safety. It provides a comprehensive overview of the regulatory landscape, implementation strategies, and the challenges faced by both health authorities and the pharmaceutical industry during the adoption process. Focusing on the European Union and key agencies like the EMA, the article highlights IDMP’s potential to improve data interoperability, streamline regulatory processes, and support cross-border healthcare services, such as e-prescriptions. Despite the significant promise of IDMP, challenges such as technical integration, high resource requirements, and ensuring data quality remain critical hurdles. By examining regulatory developments, case studies, and best practices, this paper emphasizes the transformative potential of IDMP in achieving efficient, interoperable regulatory data management, ultimately contributing to safer and more effective healthcare delivery.

Keywords: Medicinal Product Identification; Global Pharmacovigilance; Data Interoperability; IDMP Implementation Challenges; ISO IDMP; SPOR (search for similar items in EconPapers)
Date: 2024
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Persistent link: https://EconPapers.repec.org/RePEc:vrs:eurstu:v:11:y:2024:i:1:p:274-299:n:1012

DOI: 10.2478/eustu-2024-0012

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