Medicines Regulation in Africa: Current State and Opportunities
Medicines Regulation in Africa: Current State and Opportunities
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DOI：
10.1007/s40290-017-0210-x
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发表时间：
2017-12-01
影响因子：
2.5
通讯作者：
Kaale, Eliangiringa
中科院分区：
文献类型：
--
作者：
Ndomondo-Sigonda, Margareth;Miot, Jacqueline;Kaale, Eliangiringa
健全的监管制度对于保护公众健康，防止使用不符合国际质量、安全和功效标准的医疗产品至关重要。本综述总结了非洲国家药品监管机构（NMRA）的现状，以及为提高其绩效而制定的各种举措。非洲所有国家（撒哈拉共和国除外）都有国家监测和报告机构，但其组织结构和职能各不相同。有些设在卫生部内，有些则是半自治的。监管能力逐步提高，特别是在质量控制和上市后监测、药物警戒和临床试验监督方面。非洲疫苗监管论坛、非洲药品监管协调倡议、官方药品控制实验室网络和世卫组织资格预审计划帮助各国加强了监管能力。2018年可能成立的非洲药品管理局（AMA）是提高非洲国家药品监管机构能力的一个机会。
Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Some are located within Ministries of Health and others are semi-autonomous. There is progressive improvement in regulatory capacity, particularly in quality control and post-marketing surveillance, pharmacovigilance and clinical trials oversight. The African Vaccines Regulatory Forum, African Medicines Regulatory Harmonization Initiative, Network of Official Medicines Control Laboratories and WHO Prequalification Scheme have helped countries strengthen their regulatory capacities. The potential establishment of the African Medicines Agency (AMA) in 2018 is an opportunity to improve NMRAs' capacity in Africa.