识别和计算中西非洲药品监管中常见的差距和成本
Claudia P Alfonso1, Guy B N'Jambong2,3, Alaa Magdy1
1Regulatory Systems Strengthening, World Health Organization, Geneva, Switzerland.
Frontiers in medicine
|April 25, 2024
概括
加强非洲的监管体系至关重要. 这项研究发现了10个国家监管机构的共同缺陷,估计需要330万美元用于区域解决这些缺陷,以改善获得安全医疗产品的机会.
科学领域:
- 药品监管法规 药品监管法规 药品监管法规
- 加强卫生系统 加强卫生系统
- 非洲监管协调非洲监管协调
背景情况:
- 加强监管系统对于获得安全医疗产品和健康技术 (MPHT) 至关重要.
- 区域方法来识别和解决监管差距可以支持非洲医学机构.
- 国家监管机构 (NRA) 经常面临着影响MPHT质量和访问的共同挑战.
研究的目的:
- 在非洲10个国家监管机构中发现共同的监管差距.
- 从区域角度估计解决这些差距的成本.
- 提出一种加强区域监管体系的方法.
主要方法:
- 一项采用世卫组织全球基准测试工具 (GBT) 的横截面研究.
- 来自ECCAS和ECOWAS成员国的10个国家监管机构的自我评估结果 (2020-2021年).
- 分析的重点是四个关键的监管支柱.
主要成果:
- 所有10个国家监管机构都在低成熟度级别 (ML1-2) 运行,阻碍了MPHT质量保证和应急响应.
- 在良好的监管实践,应急准备,质量管理系统以及打击低标准/伪造的MPHT方面发现了共同的缺口.
- 估计在区域范围内解决这些差距的成本为330万美元.
结论:
- 开发了一种可重复的自下而上的方法,以加强区域一级的监管系统.
- 区域经济共同体 (REC) 可以利用这种方法来共同填补差距.
- 加强区域性的监管体系,可以改善公平获得保证质量的MPHT.
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