School of Pharmacy, University of the Western Cape, Private Bag X17, Bellville, 7535, South Africa.
Pharmaceut Med. 2022 Apr;36(2):83-97. doi: 10.1007/s40290-022-00425-z. Epub 2022 Apr 5.
The medicines regulatory landscape in Africa is undergoing transformation with at least two countries having National Medicines Regulatory Authorities (NRAs) that operate at World Health Organization (WHO) maturity level 3. However, this represents the exception as over 90% of African NRAs have limited capacity to perform core medicine regulatory functions, have a shortage of competent regulatory professionals, have high staff turnover, lack diversity of scientific expertise, and have staffing shortages relative to the high workload. A systematic approach to developing the regulatory workforce is therefore crucial to addressing the existing shortfalls in regulatory capacity, particularly at this time when efforts are underway to operationalise the African Medicines Agency (AMA). In this article, initiatives that are building African NRAs' regulatory capacity and developing their workforce are reviewed in preparation for work to be conducted by the AMA. We found that the African Medicines Regulatory Harmonisation (AMRH) initiative has been at the forefront of capacity building and workforce development mainly through the designation of specialised Regional Centres of Regulatory Excellence and the implementation of medicines regulatory harmonisation initiatives in regional economic communities. In addition, some NRAs within high-income countries and trusted institutions have been supporting regulators in low-income countries with registration assessments and facilitating access to quality-assured medical products through their stringent review procedures (SRPs). Capacity building has subsequently been facilitated through this active involvement of African regulators in SRPs. This article also provides recommendations for further capacity building and workforce development.
非洲的药品监管格局正在发生转变，至少有两个国家的国家药品监管机构（NRA）达到了世界卫生组织（WHO）成熟度级别 3。然而，这只是例外情况，超过 90%的非洲 NRA 机构在执行核心药品监管职能方面能力有限，缺乏合格的监管专业人员，人员流动率高，缺乏科学专业知识的多样性，与高工作量相比人员配备不足。因此，系统的方法来发展监管人员队伍对于解决监管能力的现有差距至关重要，特别是在当前正在努力使非洲药品管理局（AMA）运作的时候。本文回顾了为 AMA 的工作做准备而正在进行的非洲 NRA 监管能力建设和人员队伍发展计划。我们发现，非洲药品监管协调（AMRH）倡议一直在能力建设和人员队伍发展方面处于领先地位，主要是通过指定专门的区域监管卓越中心和在区域经济共同体中实施药品监管协调倡议。此外，一些高收入国家的 NRA 和受信任的机构通过其严格的审查程序（SRP）支持低收入国家的监管机构进行注册评估，并为其提供质量保证的医疗产品。通过非洲监管机构积极参与 SRP，随后促进了能力建设。本文还为进一步的能力建设和人员队伍发展提供了建议。
