马拉维和尼日利亚的传统医学监管现状和挑战
J S Mponda1,2,3, A S Muula4,5, A Choko6
1Department of Pharmacognosy, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria. jmponda@kuhes.ac.mw.
BMC complementary medicine and therapies
|February 14, 2025
概括
马拉维的草药法规薄弱,制造合规性差,造成公共卫生风险. 尼日利亚拥有更好的框架,但需要更强有力的执法来确保安全和质量.
科学领域:
- 药理学 药理学是指药理学的学科.
- 公共卫生 公共卫生
- 监管科学 监管科学
背景情况:
- 世界卫生组织倡导建立传统医学监管的法律框架.
- 撒哈拉以南非洲对传统医学立法和制造实践的研究有限.
- 本研究探讨了马拉维和尼日利亚传统医药的监管环境和挑战.
研究的目的:
- 评估马拉维和尼日利亚传统药物的监管状况.
- 确定制造商在遵守良好制造实践 (GMP) 时所面临的挑战.
- 评估草药的监管框架,特别是那些被艾滋病毒和艾滋病感染者使用的草药.
主要方法:
- 进行了一项描述性的横截面研究.
- 数据采集使用结构化问卷和监管要求的检查清单.
- 与监管机构和卫生部的23名官员进行了采访.
- 评估了31个制造商和66个 (马拉维) 和28个 (尼日利亚) 草药产品.
主要成果:
- 在检查清单上,马拉维的监管机构得分为7.7%,卫生部得分为28.6%;尼日利亚分别得分为77.0%和71.4%.
- 两国都没有将传统医学纳入医疗保健系统,也没有专门的实践法规.
- 马拉维制造商在卫生,设备清洁,储存和文档方面表现出不良的GMP合规性.
- 在这两个国家发现了显著的标签不合规,特别是在活性成分,数量,副作用和储存条件方面.
结论:
- 马拉维迫切需要为草药制定一个强有力的监管框架和GMP指南.
- 尼日利亚的监管框架较为发达,但需要加强对GMP和安全标准的执行.
- 改善两国监管监督和合规性对于公共卫生和消费者对传统医学的信心至关重要.
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