Abdulwahab Adeniyi Ayinde, Okafor Ukamaka Gladys, Adesuyi Damilola Samuel, Miranda Adriana Viola, Yusuf Rashidat Onyinoyi, Eliseo Lucero-Prisno Don
Faculty of Pharmaceutical Sciences Bayero University Kano Nigeria.
Department of Global Health and Bioethics Euclid University Bangui Central African Republic.
Health Care Sci. 2024 Oct 10;3(5):350-359. doi: 10.1002/hcs2.117. eCollection 2024 Oct.
In response to the situation of the African healthcare system, the African Medicines Agency (AMA) was established by the African Union (AU) to regulate access to medicines and support the local manufacture of medications. This study aimed to describe the factors that enabled the establishment of the African Medicines Agency and its successes, challenges, and perceived benefits. We reviewed data sources that explored the progress and challenges of the African Medicines Agency and Medicines Regulation in Africa. The SPIDER framework was used to organise the research focus and to extract the keywords for the literature search. The study data were obtained from PubMed Central, ScienceDirect, and Google Scholar. Out of 249 studies screened, 19 were selected for this narrative review. Critical successes observed in the agency's establishment include the appointment of a Special Envoy, the selection of its headquarters, and the signing of its treaty by 37 member states. However, it is hindered by poor political commitment, differences in risk-benefits interpretation and organizational structure, weak legal and regulatory frameworks, inadequate financial mechanisms, and inadequate political and policy leadership in some member states. The value of AMA in achieving optimal health outcomes and its other benefits must be considered despite the challenges being encountered. Therefore, all member states should adopt the best procedures in signing and ratifying the treaty and implementing associated commitments to improve efficiency and accountability in African medicine regulation.
为应对非洲医疗体系的状况，非洲联盟（AU）设立了非洲药品管理局（AMA），以规范药品获取并支持药品的本地生产。本研究旨在描述促成非洲药品管理局成立的因素及其取得的成功、面临的挑战和感知到的益处。我们回顾了探讨非洲药品管理局及非洲药品监管的进展与挑战的数据源。采用SPIDER框架来组织研究重点并提取文献检索的关键词。研究数据来自于PubMed Central、ScienceDirect和谷歌学术。在筛选的249项研究中，有19项被选入本叙述性综述。在该机构成立过程中观察到的重大成功包括任命了一位特使、选定了总部以及37个成员国签署了其条约。然而，它受到政治承诺不足、风险效益解读和组织结构差异、法律和监管框架薄弱、财政机制不足以及一些成员国政治和政策领导力不足的阻碍。尽管遇到了这些挑战，但必须考虑AMA在实现最佳健康结果方面的价值及其其他益处。因此，所有成员国在签署和批准该条约以及履行相关承诺时应采用最佳程序，以提高非洲药品监管的效率和问责制。
