Sithole Tariro, Mahlangu Gugu, Capote Velma, Sitoie Tania, Shifotoka Saren, Gaeseb Johannes, Danks Lorraine, Nkambule Portia, Juma Alex, 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 (MCAZ), Harare, Zimbabwe.
Front Med (Lausanne). 2021 Aug 27;8:742200. doi: 10.3389/fmed.2021.742200. eCollection 2021.
Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and preventing duplication of work. Various initiatives on the African continent include ZaZiBoNa, the Southern African Development Community (SADC) collaborative medicines registration initiative. ZaZiBoNa has resulted in great savings in time and resources; however, identified challenges include lack of clear information regarding the participating countries registration processes and requirements as well as lengthy registration times. The aim of this study, therefore, was to compare the data requirements and review models employed in the assessment of applications for registration, the target timelines for key milestones and the metrics of applications received and approved in 2019 and 2020 by Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe. A senior member of the division responsible for issuing marketing authorisations completed an established and validated questionnaire, which standardizes 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 majority of applications received and approved by all six agencies in 2019 and 2020 were for generics. The mean approval times for generics varied across the countries, with ranges of 218-890 calendar days in 2019 and 158-696 calendar days in 2020. All three types of scientific assessment review models were used by the six agencies and data requirements and extent of scientific assessment were similar for five countries, while one conducted full reviews for new active substances. A large variation was observed in the targets set by the six agencies for the different milestones as well as overall approval times. The study identified the strengths of the countries as well as opportunities for improvement and alignment. Implementation of the recommendations made as in this study will enhance the countries' individual systems, enabling them to efficiently support the ZaZiBoNa initiative.
在过去几年中，监管依赖、协调统一和工作共享不断发展，使得监管机构之间的工作和信息共享更加充分，从而能够有效利用有限资源并避免工作重复。非洲大陆的各种举措包括“ZaZiBoNa”以及南部非洲发展共同体（SADC）的药品注册合作倡议。“ZaZiBoNa”已在时间和资源方面实现了大幅节省；然而，发现的挑战包括缺乏关于参与国注册流程和要求的明确信息以及注册时间过长。因此，本研究的目的是比较莫桑比克、纳米比亚、南非、坦桑尼亚、赞比亚和津巴布韦在2019年和2020年评估注册申请时所采用的数据要求和审查模式、关键里程碑的目标时间线以及收到和批准的申请指标。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，该问卷使审查过程标准化，从而能够识别和比较六个监管机构的关键里程碑、活动和做法。填写完成的问卷由各机构负责人进行了验证。2019年和2020年所有六个机构收到并批准的大多数申请都是仿制药。仿制药的平均批准时间因国家而异，2019年为218 - 890个日历日，2020年为158 - 696个日历日。六个机构都使用了所有三种类型的科学评估审查模式，五个国家的数据要求和科学评估程度相似，而有一个国家对新活性物质进行全面审查。六个机构为不同里程碑设定的目标以及总体批准时间存在很大差异。该研究确定了各国的优势以及改进和协调的机会。实施本研究中提出的建议将加强各国的各自体系使其能够有效地支持“ZaZiBoNa”倡议。
