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

Summary 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.

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Publication Details

Journal
European Studies. The Review of European Law, Economics and Politics
Published
2024-09-01
DOI
https://doi.org/10.2478/eustu-2024-0012
Primary Topic
Pharmaceutical Economics and Policy
Type
article
Field-Weighted Citation Impact
0.00
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article

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

K. Bryce Jones
European Studies. The Review of European Law, Economics and Politics
Pharmaceutical Economics and Policy
article

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

K. Bryce Jones
article en

Abstract

Summary 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.

European Studies. The Review of European Law, Economics and PoliticsVol. 11(1)
Tallinn University of Technology (EE)
Openalex Percentile: Top 67%
Pharmaceutical Economics and Policy
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Adoption of Identification of Medicinal Products Standards in Europe: Health Authorities and Industry Insights — K. Bryce Jones · European Studies. The Review of European Law, Economics and Politics (2024) | TGRS Research Map | TGRS