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).
Institutions
- American Pharmacists Association (US)
- Ministry of Health and Social Services (NA)
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
- Field-Weighted Citation Impact
- 0.00