Sithole Tariro, Salek Sam, Mahlangu Gugu, Walker Stuart
School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK.
Medicines Control Authority of Zimbabwe, Zimbabwe.
Expert Rev Clin Pharmacol. 2022 Jan;15(1):109-119. doi: 10.1080/17512433.2022.1987883. Epub 2021 Oct 20.
Benchmarking regulatory systems of low- and middle-income countries with mature systems provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients' access to medicines. The aim of this study was to compare the medicines registration process of the Medicines Control Authority of Zimbabwe (MCAZ) with the regulatory processes in Australia, Canada, Singapore, and Switzerland.
A questionnaire that standardizes the review process, allowing key milestones, activities and practices of the five regulatory authorities was completed by a senior member of the divisions responsible for issuing marketing authorizations.
The MCAZ has far fewer resources than the regulatory authorities in the comparator countries, but employs three review models, which is in line with international best practice. The MCAZ registration process is similar to the comparator countries in key milestones monitored, but differs in the target timelines for these milestones. The MCAZ is comparable to the comparator authorities in implementing the majority of good review practices, although it significantly lags behind in transparency and communication.
This study identified the MCAZ strengths and opportunities for improvement, which if implemented, will enable the achievement of its vision to be a leading regulatory authority in Africa.
将低收入和中等收入国家的监管体系与成熟体系进行对标，为找出差距、提高审评质量和缩短注册时间提供了契机，从而改善患者获得药品的机会。本研究的目的是比较津巴布韦药品控制局（MCAZ）的药品注册流程与澳大利亚、加拿大、新加坡和瑞士的监管流程。
一份使审评流程标准化的问卷，涵盖了五个监管机构的关键节点、活动和做法，由负责发放上市许可的部门的一名高级成员填写。
与对照国家的监管机构相比，MCAZ的资源要少得多，但采用了三种审评模式，这符合国际最佳实践。MCAZ的注册流程在监测的关键节点方面与对照国家相似，但这些节点的目标时间线有所不同。在实施大多数良好审评实践方面，MCAZ与对照机构相当，尽管在透明度和沟通方面明显滞后。
本研究确定了MCAZ的优势和改进机会，如果加以实施，将使其有机会实现成为非洲领先监管机构的愿景。
