Dube-Mwedzi S, Kniazkov S, Nikiema J B, Kasilo O M J, Fortin A, Tumusiime P, Mahlangu G N, Ndomondo-Sigonda M
SADC Medicines Regulatory Harmonization Project, Harare, Zimbabwe.
WHO Regional Office for Africa, Health Technologies and Innovation Unit, Brazzaville, Republic of Congo.
J Pharm Policy Pract. 2020 Oct 5;13:64. doi: 10.1186/s40545-020-00255-x. eCollection 2020.
Access to quality-assured, safe and efficacious medical products is fundamental for Universal Health Coverage and attaining Sustainable Development Goal 3: Ensure Healthy Lives and Well-being for All. To guarantee this right, there is a need for robust and efficiently performing national regulatory systems for the regulation of medical products. Well-functioning regulatory systems apply globally accepted standards which ensure that the level of control is proportionate to the level of public health risk.
The study aimed at analysing the regulatory systems for medical products in the 16 Member States of the Southern African Development Community (SADC). It provides an overview of the national regulatory systems for medical products in the region in 2017 and outlines the institutional frameworks, which enable the implementation of regulatory functions.
A survey was conducted in March-December 2017 in English, French and Portuguese. National Regulatory Authorities for medical products (NMRAs) of the 16 Member States within SADC responded to the questions asked and sent in their answers. The survey was constructed around five themes instrumental for implementation of the Universal Health Coverage actions framework. Three of the themes are discussed in this article.
The outcome of the survey demonstrates that within SADC, NMRAs vary in terms of organisational set-up and modalities of medical product regulation. The majority are within the Ministries of Health, and a few are either semi-autonomous or autonomous. Legal frameworks for medical products are in place for some of the SADC NMRAs, although they vary in the scope of products subject to regulation. Traditional medicines, biologicals and medical devices are regulated, however not uniformly across the region.
Despite major progress over the years, the survey demonstrates variable levels of governance and regulatory framework among NMRAs in SADC. The survey supports the need for shifting from the broad strengthening of the regulatory systems which exist and are underpinned by the mandates, to more product-type focused approaches. This shift will ensure that medical products are quality-assured, safe and effective for a performant Health Systems attainment of the Universal Health Coverage and Sustainable Development Goals.
获得质量有保证、安全且有效的医疗产品是全民健康覆盖以及实现可持续发展目标3（确保所有人享有健康生活和福祉）的基础。为保障这一权利，需要有强大且高效运行的国家医疗产品监管体系。运转良好的监管体系采用全球公认的标准，以确保管控水平与公共卫生风险水平相称。
本研究旨在分析南部非洲发展共同体（SADC）16个成员国的医疗产品监管体系。它概述了2017年该地区国家医疗产品监管体系，并勾勒了能够实施监管职能的机构框架。
2017年3月至12月以英语、法语和葡萄牙语进行了一项调查。SADC的16个成员国的国家医疗产品监管当局（NMRA）回答了所提问题并提交了答案。该调查围绕对实施全民健康覆盖行动框架有帮助的五个主题构建。本文讨论其中三个主题。
调查结果表明，在SADC内部，NMRA在组织架构和医疗产品监管方式方面各不相同。大多数隶属于卫生部，少数是半自治或自治的。一些SADC的NMRA有医疗产品法律框架，尽管受监管产品的范围各不相同。传统药品、生物制品和医疗器械都受到监管，但该地区并不统一。
尽管多年来取得了重大进展，但调查表明SADC的NMRA之间治理水平和监管框架存在差异。该调查支持从广泛加强现有且由任务授权支撑的监管体系，转向更注重产品类型的方法。这一转变将确保医疗产品质量有保证、安全且有效，以实现高效的卫生系统达成全民健康覆盖和可持续发展目标。
