A comparative analysis of Namibia's medicines regulatory authority with regulatory authorities of South Africa, the United States of America, and the United Kingdom

Background: Little attention has been paid to the principle of the independence of medicine regulatory authorities, agencies, or boards, especially in Africa, despite their role in ensuring the availability of safe, effective, and affordable pharmaceuticals to society. Methods: Data was collected using information from the Acts, Laws, legislation, and regulations available in the public domain. Standard Gilardi and INDREG questionnaires were used to collect data to assess the legal status, adequacy of human and financial resources, role clarity, transparency, and accountability of regulators, which could be answered through desk research. Findings: The average overall independence for all four agencies is 59%, with a standard deviation of 10%. The study results further revealed that the national regulatory authorities have significant protection above average from external influence though they are not entirely independent. Conclusion: The four agencies have comparable regulatory independence and similar protection from undue external influence. Namibia's medicines regulatory independence level is not significantly different from that of South Africa, the United Kingdom (UK), and the United States of America (U.S.A).

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Publication Details

Journal
GSC Biological and Pharmaceutical Sciences
Published
2024-08-11
DOI
https://doi.org/10.30574/gscbps.2024.28.2.0288
Primary Topic
International Environmental Law and Policies
Type
article
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article

A comparative analysis of Namibia's medicines regulatory authority with regulatory authorities of South Africa, the United States of America, and the United Kingdom

Wellington Ndaradzi, Abraham Dongo
2 links
GSC Biological and Pharmaceutical Sciences
International Environmental Law and Policies
article

A comparative analysis of Namibia's medicines regulatory authority with regulatory authorities of South Africa, the United States of America, and the United Kingdom

Wellington Ndaradzi, Abraham Dongo
article en

Abstract

Background: Little attention has been paid to the principle of the independence of medicine regulatory authorities, agencies, or boards, especially in Africa, despite their role in ensuring the availability of safe, effective, and affordable pharmaceuticals to society. Methods: Data was collected using information from the Acts, Laws, legislation, and regulations available in the public domain. Standard Gilardi and INDREG questionnaires were used to collect data to assess the legal status, adequacy of human and financial resources, role clarity, transparency, and accountability of regulators, which could be answered through desk research. Findings: The average overall independence for all four agencies is 59%, with a standard deviation of 10%. The study results further revealed that the national regulatory authorities have significant protection above average from external influence though they are not entirely independent. Conclusion: The four agencies have comparable regulatory independence and similar protection from undue external influence. Namibia's medicines regulatory independence level is not significantly different from that of South Africa, the United Kingdom (UK), and the United States of America (U.S.A).

GSC Biological and Pharmaceutical SciencesVol. 28(2)
Peace, Justice and strong institutions
Openalex Percentile: Top 82%
International Environmental Law and Policies
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A comparative analysis of Namibia's medicines regulatory authority with regulatory authorities of South Africa, the United States of America, and the United Kingdom — Wellington Ndaradzi, Abraham Dongo · GSC Biological and Pharmaceutical Sciences (2024) | TGRS Research Map | TGRS