Transitioning to regulatory harmonisation for medicines: a comparison between Africa and Europe

IF 7.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Discovery Today Pub Date : 2025-06-23 DOI:10.1016/j.drudis.2025.104416

Kirti Narsai , Hubert G.M. Leufkens , Francine Brinkhuis , Aukje K. Mantel-Teeuwisse , Hendrika A. van den Ham

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引用次数: 0

Abstract

The harmonisation of medicines regulation has varied across regions. Europe began over 50 years ago, whereas Africa started only recently through regional initiatives. We compared regulatory developments in both regions, examining stakeholder influence, philosophy, funding, and systems. Key differences included legislation (common binding legislation was essential to success in Europe), economics, disease patterns, and industrial policy, while protecting health and work-sharing were common goals. Disease outbreaks drove African manufacturing and regulatory strengthening, whereas European harmonisation followed the formation of the European Union. The establishment of the European Medicines Agency in 1995 was crucial, but an African Medicines Agency remains in progress. Both regions require national support for supranational bodies. Africa has advanced in regulation recently, while Europe strengthens its system. Future health challenges require continued harmonisation efforts.

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向药品监管协调过渡：非洲和欧洲之间的比较。

药品监管的协调在不同地区有所不同。欧洲是50多年前开始的，而非洲是最近才通过区域倡议开始的。我们比较了这两个地区的监管发展，考察了利益相关者的影响力、理念、资金和制度。主要差异包括立法（共同的约束性立法对欧洲的成功至关重要）、经济、疾病模式和工业政策，而保护健康和分担工作是共同的目标。疾病爆发推动了非洲的制造业和监管加强，而欧洲的协调则是在欧盟成立之后。1995年建立欧洲药品管理局至关重要，但非洲药品管理局仍在进行中。这两个区域都需要国家支持超国家机构。非洲最近在监管方面取得了进展，而欧洲则加强了监管体系。未来的卫生挑战需要持续的协调努力。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Discovery Today 医学-药学

CiteScore

14.80

自引率

2.70%

发文量

293

审稿时长

6 months

期刊介绍： Drug Discovery Today delivers informed and highly current reviews for the discovery community. The magazine addresses not only the rapid scientific developments in drug discovery associated technologies but also the management, commercial and regulatory issues that increasingly play a part in how R&D is planned, structured and executed. Features include comment by international experts, news and analysis of important developments, reviews of key scientific and strategic issues, overviews of recent progress in specific therapeutic areas and conference reports.