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
Zenodo (CERN European Organization for Nuclear Research)
Published
2024-08-30
DOI
https://doi.org/10.5281/zenodo.14676324
Primary Topic
Pharmaceutical Quality and Counterfeiting
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

Zenodo (CERN European Organization for Nuclear Research)
Pharmaceutical Quality and Counterfeiting
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

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).

Zenodo (CERN European Organization for Nuclear Research)
American Pharmacists Association (US), Ministry of Health and Social Services (NA)
Peace, Justice and strong institutions
Openalex Percentile: Top 46%
Pharmaceutical Quality and Counterfeiting
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