Ngum Nancy, Ndomondo-Sigonda Margareth, Habonimana Rémy, Siyoi Fred, Irasabwa Clarisse, Ojukwu Julia, Apolinary Felchism, Okello Andrew, Ahmada Sabrina, Walker Stuart, Salek Sam
Department of Clinical and Pharmaceutical Sciences, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.
African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD), Johannesburg, South Africa.
Front Med (Lausanne). 2024 Aug 29;11:1437970. doi: 10.3389/fmed.2024.1437970. eCollection 2024.
The East African Community Medicines Regulatory Harmonisation (EAC-MRH) programme was established to address challenges faced by national regulatory authorities (NRAs) of the region. Work sharing through joint assessments and inspections was adopted to manage limited resources and capacity; however, NRA good review practices (GrevP) are also a key determinant to success. This study evaluated GReVP among the EAC-MRH NRAs and mapped required strategies for countries to align themselves with the African Medicines Agency (AMA).
A validated questionnaire (Optimising Efficiency in Regulatory Agency-OpERA) that standardises and captures review processes was completed by the head of the medicines registration division in each NRA. A country report based on the completed questionnaire was developed for each NRA and validated by the heads of the respective authorities.
The population and size of the NRAs vary and four of the countries have semi-autonomous authorities and three NRAs are autonomous. The Burundi and South Sudan authorities were fully government funded, Kenya and Uganda entirely from fees, while Rwanda, Tanzania and Zanzibar were partially funded from different sources. All authorities except South Sudan, which does not receive or review applications had backlogs. Authority fees varied based on the different application categories. Key milestones for standardised regulatory processes are implemented in all authorities. Queue times range from a few weeks to about one year. Three NRAs use internal technical agency staff for scientific assessments and three use both internal and external experts. Clock stop time varies and target timelines for review committee range from one day to three months. All the NRAs implement some best practices on quality measures, transparency and communication. Some have activities for transparency improvement but with minimal attention to training and education. Most employ some quality decision-making practices.
GrevP in EAC-MRH NRAs still needs to be improved and it is imperative that these authorities streamline and harmonise their practices. Increasing human resources and an investment in training and education of staff will enable the implementation of all measures for GRevP. This is vital, as the effectiveness and efficiency of the AMA will depend on the strength of these NRAs.
东非共同体药品监管协调（EAC-MRH）计划的设立是为了应对该地区各国药品监管机构（NRA）所面临的挑战。通过联合评估和检查来进行工作分担，以管理有限的资源和能力；然而，NRA的良好审评规范（GrevP）也是成功的关键决定因素。本研究评估了东非共同体药品监管协调计划中各国药品监管机构的良好审评规范，并梳理了各国为与非洲药品管理局（AMA）保持一致所需的策略。
由每个药品监管机构药品注册部门负责人填写一份经过验证的调查问卷（优化监管机构效率-OpERA），该问卷可对审评流程进行标准化并记录相关信息。根据填写完成的调查问卷为每个药品监管机构编制一份国家报告，并由各自监管机构的负责人进行验证。
各国药品监管机构的人员数量和规模各不相同，其中四个国家的监管机构为半自治机构，三个为自治机构。布隆迪和南苏丹的监管机构完全由政府资助，肯尼亚和乌干达完全靠收费维持，而卢旺达、坦桑尼亚和桑给巴尔则部分资金来自不同来源。除南苏丹（不接收或审评申请）外，所有监管机构都有积压的申请。根据不同的申请类别，收费标准也有所不同。所有监管机构都实施了标准化监管流程的关键节点。排队时间从几周到大约一年不等。三个药品监管机构利用内部技术机构人员进行科学评估，三个则同时使用内部和外部专家。时钟停止时间各不相同，审评委员会的目标时间从一天到三个月不等 。所有药品监管机构都在质量措施、透明度和沟通方面实施了一些最佳实践。一些机构开展了提高透明度的活动，但对培训和教育的关注较少。大多数机构采用了一些质量决策实践。
东非共同体药品监管协调计划中各国药品监管机构的良好审评规范仍需改进，这些机构必须精简并统一其做法。增加人力资源以及对员工培训和教育的投入将有助于实施良好审评规范的所有措施。这至关重要，因为非洲药品管理局的有效性和效率将取决于这些药品监管机构的实力。
