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.
Authors
- Mercy Owusu-Asante
- Sam Salek (ORCID: https://orcid.org/0000-0002-4612-5699)
- Adam Mitangu Fimbo (ORCID: https://orcid.org/0000-0002-9356-2218)
- Christianah Mojisola Adeyeye
- Stuart Walker (ORCID: https://orcid.org/0000-0002-7688-5306)
- Delese Mimi Darko
- Richard T. Rukwata
- Boitumelo Semete-Makokotieia
- Ghada Zaki
Institutions
- 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)
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
- 0.00