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扩大监管科学:监管互补性和依赖性
Jackson K Mukonzo1, Helen Byomire Ndagije2, George Tsey Sabblah3
1Department of Pharmacology & Therapeutics, Makerere University, College of Health Science, Kampala, Uganda.
Clinical and translational science
|November 14, 2023
概括
监管依赖在全球范围内日益增长,但往往忽视了低收入和中等收入国家 (LMICs) 的见解. 采用"监管互补性"可以通过重视各种背景知识来加强全球药物监管.
科学领域:
- 监管科学 监管科学
- 全球卫生政策 全球卫生政策
- 药物监管 药物监管 药物监管
背景情况:
- 全球药物监管系统越来越相互联系,促进国际合作.
- 监管依赖计划旨在加强监管能力,特别是在低收入和中等收入国家 (LMICs).
- 目前的框架往往侧重于从高收入国家 (HIC) 到LMIC的知识转移.
研究的目的:
- 挑战全球药物监管中的单向知识转移模式.
- 引入并倡导"监管互补性"作为监管科学的一个重要维度.
- 突出LMIC卫生研究人员和监管机构的上下文见解的价值.
主要方法:
- 这是一个立场论文,提出了一个概念论证.
- 它分析了监管依赖和能力建设倡议的当前框架.
- 它提出了一个新的框架",监管互补性",以加强全球监管科学.
主要成果:
- 目前的监管依赖框架可能低估了LMIC监管机构的独特贡献.
- 系统地识别和分享各种背景见解可以丰富监管审议.
- 监管互补性为一个更强大,更具包容性的全球监管生态系统提供了途径.
结论:
- 通过监管互补性来评估和整合LMIC的观点,可以显著增加全球药物监管.
- 这种方法超越了简单的知识转移,促进了真正的协作和丰富的全球监管环境.
- 监管互补性对于未来有效和公平的全球药物监管至关重要.
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