埃塞俄比亚制药监管的教训:以风险为基础的方法来克服挑战并释放机会
Hassen Kebede Hassen1, Yesuneh Tefera Mekasha2, Addisu Afrassa Tegegne3
1Veterinary Drug Quality and Standards Regulatory Unit, Ethiopian Agricultural Authority, Addis Ababa, Ethiopia.
Frontiers in medicine
|September 22, 2025
概括
埃塞俄比亚 埃塞俄比亚 埃塞俄比亚
科学领域:
- 药品监管法规 药品监管法规 药品监管法规
- 药品质量 药品质量 药品质量
- 供应链管理 供应链管理
背景情况:
- 制药产品对公共卫生至关重要,但在资源有限的环境中,质量和获取受到挑战.
- 埃塞俄比亚面临监管系统问题和缺乏最新的质量信息,这阻碍了获得安全药物的机会.
研究的目的:
- 检查埃塞俄比亚制药监管中的挑战和机遇.
- 通过回顾性数据分析目前对人用药品的监管前景.
主要方法:
- 来自在线数据库的回顾性数据分析 (PubMed,科学网,谷歌学者).
- 通过专注组讨论和调查与专家和利益相关者进行跨部门监管分析.
- 组织和过数据的描述性分析,通过表格,流程图和叙述呈现.
主要成果:
- 从埃塞俄比亚市场抽取的21.4%的制药品质量不佳.
- 供应链的约束包括低于最佳的数量 (36.17%),品种有限 (55.32%),外汇问题 (65.96%),高腐败率 (85%) 和品牌依赖 (27.7%).
- 埃塞俄比亚食品和药物管理局 (EFDA) 面临着申请积压,业绩不足 (RPN=75),缺乏透明度 (RPN=64),以及文档问题.
结论:
- 监管过程中的挑战表现为质量不佳的产品和执法缺陷.
- 制药供应链问题影响药物的安全性和有效性.
- 基于风险分析的系统重新设计和改进的监管基础设施对于缓解质量和安全问题至关重要.
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