School of Pharmacy, University of the Western Cape, Private Bag X17, Bellville 7535, South Africa.
Health Policy Plan. 2024 May 15;39(5):447-456. doi: 10.1093/heapol/czae017.
The vision of the African Medicines Agency (AMA) is to ensure that all Africans have access to affordable medical products that meet internationally recognized standards of quality, safety and efficacy for priority diseases/conditions. The AMA is being established by a treaty which had to be ratified by a minimum of 15 African countries. Although there was no deadline, the ratification process has been slower than expected. This study therefore analysed the rationale, perceived benefits, enabling factors and challenges of the AMA's establishment. This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of 45 African countries. The Heads of NRAs and a senior NRA staff member were contacted to complete self-administered questionnaires. The existence of mature NRAs, the desire to have harmonized regulatory systems, the presence of strong political will and appropriate advocacy to expedite treaty signing are all enabling factors for AMA treaty signing. The challenges reported include the fact that the process is slow and there is limited understanding of the process. Competing national priorities, changes in office bearers in the public system and stagnation of the process at the ministerial level were also challenges reported. This study has improved the understanding of the treaty signing and ratification process and the perceived benefits and enabling factors of signing and ratification from African NRAs' perspective. NRAs also highlighted challenges encountered in the process. Addressing these challenges will result in effective medicines regulation by galvanizing technical support, regulatory expertise and resources at a continental level.
非洲药品管理局（AMA）的愿景是确保所有非洲人都能获得负担得起的医疗产品，这些产品符合国际公认的质量、安全和疗效标准，用于优先疾病/状况。AMA 是根据一项条约设立的，该条约必须得到至少 15 个非洲国家的批准。尽管没有最后期限，但批准进程的速度比预期的要慢。因此，本研究分析了 AMA 成立的基本原理、预期收益、促成因素和挑战。本研究是对 45 个非洲国家的国家药品监管机构（NRAs）进行的定性、横断面、普查调查。联系了 NRA 的负责人和一名 NRA 的高级工作人员，让他们填写自我管理的问卷。成熟的 NRA 的存在、对协调监管系统的渴望、强烈的政治意愿以及加快条约签署的适当宣传，都是 AMA 条约签署的促成因素。报告的挑战包括该进程缓慢，而且对该进程的理解有限。竞争激烈的国家优先事项、公共系统中任职人员的变动以及部长级别的进程停滞不前，也是报告的挑战。本研究从非洲 NRA 的角度增进了对条约签署和批准过程以及签署和批准的预期收益和促成因素的理解。NRA 还强调了在该进程中遇到的挑战。解决这些挑战将通过在大陆层面上激发技术支持、监管专业知识和资源，从而实现有效的药品监管。
