Sithole Tariro, Mahlangu Gugu, Capote Velma, Sitoie Tania, Shifotoka Saren, Gaeseb Johannes, Padayachee Silverani, Sehloho Tohlang, Khea Akida, Fimbo Adam, Munkombwe Zuma, Mwale Bernice, Salek Sam, Walker Stuart
School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.
Medicines Control Authority of Zimbabwe, Harare, Zimbabwe.
Front Med (Lausanne). 2021 Aug 27;8:742181. doi: 10.3389/fmed.2021.742181. eCollection 2021.
National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the review process to facilitate access to quality-assured medicines by their populations. One such collaboration is the Southern African Development Community (SADC) medicines registration collaborative initiative, ZaZiBoNa. Countries participate in the initiative by contributing to regulatory reviews and good manufacturing practices inspections. The aim of this study was to review and compare the registration processes of regulatory authorities of Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe to identify strategies for better alignment. A senior member of the division responsible for issuing marketing authorisations completed an established and validated questionnaire, which standardises the review process, allowing key milestones, activities and practices of the six regulatory authorities to be identified and compared. The completed questionnaires were validated by the heads of the respective agencies. The six countries vary in population and in the size of their respective regulatory agency and the resources allocated to regulatory reviews. The review processes of the six agencies were similar; however, differences were noted in the milestones recorded; for example, two of the countries did not record the start of the scientific assessment. Additionally, decisions for marketing authorisation were made by an expert committee in four of the countries and by the head of the agency and the Minister of Health in two countries. All six agencies implemented the majority of good review practices; however, the need for improvement in the areas of transparency and communication and quality decision making practices was a common finding for all six countries. Participation in the ZaZiBoNa initiative has improved the way in which the six agencies perform regulatory reviews in their countries, highlighting the realisation of one of the key objectives of the initiative, which was building the expert capacity of member countries. Other agencies in the SADC region and beyond can use the results of this study to identify best practices, which in turn, could improve their regulatory performance.
国家药品监管机构面临着包括资源和技术能力有限在内的挑战，这导致各国开展合作并共享资源，以提高审评流程的效率，从而便于民众获取质量有保证的药品。其中一项合作是南部非洲发展共同体（SADC）药品注册合作倡议“ZaZiBoNa”。各国通过参与监管审评和药品生产质量管理规范检查来参与该倡议。本研究的目的是审评和比较莫桑比克、纳米比亚、南非、坦桑尼亚、赞比亚和津巴布韦监管当局的注册流程，以确定更好地实现协调一致的策略。负责发放上市许可的部门的一名高级成员完成了一份既定且经过验证的问卷，该问卷使审评流程标准化，从而能够识别和比较六个监管当局的关键节点、活动及做法。填写完整的问卷由各机构负责人进行了验证。这六个国家在人口数量、各自监管机构的规模以及分配给监管审评的资源方面存在差异。六个机构的审评流程相似；然而，在记录的关键节点方面存在差异；例如，其中两个国家没有记录科学评估的开始时间。此外，四个国家由专家委员会做出上市许可决定，两个国家由机构负责人和卫生部长做出决定。所有六个机构都实施了大多数良好的审评做法；然而，所有六个国家都普遍发现，在透明度、沟通以及高质量决策做法等方面需要改进。参与“ZaZiBoNa”倡议改善了这六个机构在各自国家开展监管审评的方式，凸显了该倡议的一个关键目标的实现，即建设成员国的专家能力。南部非洲发展共同体区域及其他地区的其他机构可以利用本研究结果来确定最佳做法，进而改善其监管绩效。
