A rapid assessment of the National Regulatory Systems for medical products in the Southern African Development Community

Southern Med Review

article

Dube-Mwedzi, S.¹  Kniazkov, S.²  Nikiema, J. B.²  Kasilo, O. M. J.²  Fortin, A.²  Tumusiime, P.²  Mahlangu, G. N.³  Ndomondo-Sigonda, M.⁴ 

[1]SADC Medicines Regulatory Harmonization Project

[2]WHO Regional Office for Africa, Health Technologies and Innovation Unit

[3]Medicines Control Authority of Zimbabwe

[4]African Union Development Agency, New Partnership for Africa’s Development

关键词: Medical products;    Medicines;    Quality;    Safety;    Efficacy;    Regulation;    National Regulatory Systems;    National Regulatory Authorities;    Institutional frameworks;    South African Development Community;    UHC;    SDG;   

DOI  :  10.1186/s40545-020-00255-x

学科分类：药理学

来源: BioMed Central

【 摘 要 】

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.

【 授权许可】

Unknown