Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, College of Medicine and Allied Health Sciences, University of Sierra Leone, Freetown, Sierra Leone.
Department of Pharmacovigilance and Clinical Trials, Pharmacy Board of Sierra Leone, Freetown, Sierra Leone.
Ther Innov Regul Sci. 2024 Nov;58(6):1053-1060. doi: 10.1007/s43441-024-00683-w. Epub 2024 Aug 4.
Access to medical products of the required efficacy, quality and safety is essential for everyone's health and wellbeing. To achieve this milestone, every country needs a robust and strong performing National Regulatory Authority (NRA) that is independent and outcome oriented. With the help of the World Health Organization (WHO), the global benchmarking tool is the gold standard used to assess the regulatory capacity of NRAs.
This study assessed the capacity of the National Medicines Regulatory Authority in Sierra Leone to perform its regulatory functions.
This descriptive cross-sectional study used both qualitative and quantitative approaches. A self-administered questionnaire was used for the quantitative approach, and the qualitative aspect consisted of a desk review looking at key regulatory documents such as laws, regulations, policies, guidelines, standard operating procedures and reports. The data collection tool used was the WHO global benchmarking tool (GBT) for "Evaluation of National Regulatory System of Medical Product Version VI.
The majority of the participants had a postgraduate degree (60%), and 72% had over 10 years of experience working at the NRA. Out of 251 sub-indicators assessed, 85 (34%) sub-indicators were fully implemented. Of the eight (8) functions assessed, sub-indicators related to clinical trial oversight and vigilance were the most implemented, with 67% and 62%, respectively. Of the 9 indicators assessed, 79% of the sub-indicators that are related to quality and risk management were implemented. The results of this study showed that PBSL operates at maturity level 1. The absence of laws and regulations that give PBSL the mandate to perform its regulatory functions was a major challenge even though other indicators were met. The study reported other challenges toward effective functioning, including but not limited to a lack of sufficient staff, weak enforcement of the sale of medicines and a poorly equipped quality control laboratory.
每个人的健康和福祉都需要获得具有所需疗效、质量和安全性的医疗产品。为了实现这一里程碑，每个国家都需要一个强大的、表现出色的国家监管机构（NRA），该机构应具有独立性并注重结果。在世界卫生组织（WHO）的帮助下，全球基准工具是评估 NRA 监管能力的黄金标准。
本研究评估了塞拉利昂国家药品监管局履行其监管职能的能力。
本描述性横断面研究采用了定性和定量方法。定量方法使用了自填式问卷，定性方面包括对关键监管文件（如法律、法规、政策、指南、标准操作程序和报告）的桌面审查。使用的数据集收集工具是世界卫生组织全球基准工具（GBT），用于“评估医疗产品国家监管系统第六版”。
大多数参与者具有研究生学历（60%），并且 72%的人在 NRA 工作了 10 年以上。在所评估的 251 个子指标中，有 85 个子指标（34%）得到了全面实施。在所评估的八个（8）职能中，临床试验监督和警戒相关的子指标实施程度最高，分别为 67%和 62%。在所评估的 9 个指标中，与质量和风险管理相关的 79%的子指标得到了实施。这项研究的结果表明，PBSL 的运作成熟度为 1 级。尽管满足了其他指标，但缺乏赋予 PBSL 履行监管职能的法律和法规仍然是一个主要挑战。该研究报告了其他有效运作的挑战，包括但不限于人员不足、对药品销售的执法不力以及质量控制实验室设备简陋。
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