Regulatory Performance of African National Medicines Regulatory Authorities Achieving WHO Maturity Level 3: Identifying Best Practices

The study has identified the regulatory best practices that led to the NMRAs achieving WHO GBT maturity level 3. The African Medicines Agency should engage these maturity level-3 NMRAs to explore ways of benefiting from their experience and resources. It is hoped that through such engagement, the NMRAs will be encouraged to further develop their capacity to help the AMA to achieve its mandate. Additionally, by addressing the identified gaps and recommendations in the study these NMRAs can achieve WHO GBT maturity level 4 whilst NMRAs who have not yet reached GBT maturity level 3 can also benefit from this study in order to reach higher maturity levels.

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Publication Details

Journal
Therapeutic Innovation & Regulatory Science
Published
2025-10-27
DOI
https://doi.org/10.1007/s43441-025-00879-8
Primary Topic
Pharmaceutical Quality and Counterfeiting
Type
article
Field-Weighted Citation Impact
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article

Regulatory Performance of African National Medicines Regulatory Authorities Achieving WHO Maturity Level 3: Identifying Best Practices

Mercy Owusu-Asante, Sam Salek, Adam Mitangu Fimbo, Christianah Mojisola Adeyeye et al.
Therapeutic Innovation & Regulatory Science
Pharmaceutical Quality and Counterfeiting
article

Regulatory Performance of African National Medicines Regulatory Authorities Achieving WHO Maturity Level 3: Identifying Best Practices

Mercy Owusu-Asante, Sam Salek, Adam Mitangu Fimbo, Christianah Mojisola Adeyeye, Stuart Walker, Delese Mimi Darko, Richard T. Rukwata, Boitumelo Semete-Makokotieia, Ghada Zaki
article en

Abstract

The study has identified the regulatory best practices that led to the NMRAs achieving WHO GBT maturity level 3. The African Medicines Agency should engage these maturity level-3 NMRAs to explore ways of benefiting from their experience and resources. It is hoped that through such engagement, the NMRAs will be encouraged to further develop their capacity to help the AMA to achieve its mandate. Additionally, by addressing the identified gaps and recommendations in the study these NMRAs can achieve WHO GBT maturity level 4 whilst NMRAs who have not yet reached GBT maturity level 3 can also benefit from this study in order to reach higher maturity levels.

Therapeutic Innovation & Regulatory ScienceVol. 60(1)
University of Hertfordshire (GB), Centre for Innovation in Regulatory Science (GB), Institute of Economic Development (GB), Zimbabwe National Water Authority (ZW), Egyptian Government (EG), National Agency for the Control of AIDS (NG), Cardiff University (GB), American University in Cairo (EG)
Openalex Percentile: Top 59%
Pharmaceutical Quality and Counterfeiting
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