Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products
The World Health Organization (WHO) Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels, with Maturity Level 3 (ML3) signifying a stable and effective regulatory environment. As of January 2025, eight African nations—Egypt, Ghana, Nigeria, Rwanda, Senegal, South Af...
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MDPI AG
2025-06-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/13/6/646 |
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| author | Alemayehu Duga Nebiyu Dereje Mosoka Papa Fallah Tedi Angasa Abebe Genetu Bayih Edinam Agbenu Ngashi Ngongo Raji Tajudeen Jean Kaseya |
| author_facet | Alemayehu Duga Nebiyu Dereje Mosoka Papa Fallah Tedi Angasa Abebe Genetu Bayih Edinam Agbenu Ngashi Ngongo Raji Tajudeen Jean Kaseya |
| author_sort | Alemayehu Duga |
| collection | DOAJ |
| description | The World Health Organization (WHO) Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels, with Maturity Level 3 (ML3) signifying a stable and effective regulatory environment. As of January 2025, eight African nations—Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe—have attained ML3 status, marking a significant milestone in the continent’s regulatory landscape. Achieving ML3 confers critical benefits, including reducing substandard and falsified medicines, which enhances public health safety and fosters trust in healthcare systems. This progress encourages local manufacturing, diminishing reliance on imported medicines and promoting economic development. Furthermore, ML3 NRAs are better equipped to address public health emergencies, enabling swift approvals for vaccines and therapeutics while upholding safety standards. Nonetheless, challenges persist, including fragmented regulatory systems, the prevalence of counterfeit medicines, and limited resources. Overcoming these hurdles necessitates enhanced organizational capacity, investments in training, and the promotion of collaboration among NRAs. There is an urgent call for greater political commitment and resource allocation to strengthen regulatory systems across Africa. Achieving and maintaining ML3 status is essential for enhancing medicine regulation, supporting local manufacturing, and improving public health outcomes across the continent. While progress has been made, sustained efforts are crucial to tackling existing challenges and harnessing the full potential of advanced regulatory frameworks. |
| format | Article |
| id | doaj-art-4732a2e71d6947518d07242ce21ad9f1 |
| institution | OA Journals |
| issn | 2076-393X |
| language | English |
| publishDate | 2025-06-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj-art-4732a2e71d6947518d07242ce21ad9f12025-08-20T02:21:58ZengMDPI AGVaccines2076-393X2025-06-0113664610.3390/vaccines13060646Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health ProductsAlemayehu Duga0Nebiyu Dereje1Mosoka Papa Fallah2Tedi Angasa3Abebe Genetu Bayih4Edinam Agbenu5Ngashi Ngongo6Raji Tajudeen7Jean Kaseya8Africa Centres for Disease Control and Prevention, Addis Ababa 3243, EthiopiaAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, EthiopiaAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, EthiopiaAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, EthiopiaAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, EthiopiaIntercountry Support Team, Regional Office for Africa, World Health Organization, Ouagadougou 100701, Burkina FasoAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, EthiopiaAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, EthiopiaAfrica Centres for Disease Control and Prevention, Addis Ababa 3243, EthiopiaThe World Health Organization (WHO) Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels, with Maturity Level 3 (ML3) signifying a stable and effective regulatory environment. As of January 2025, eight African nations—Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe—have attained ML3 status, marking a significant milestone in the continent’s regulatory landscape. Achieving ML3 confers critical benefits, including reducing substandard and falsified medicines, which enhances public health safety and fosters trust in healthcare systems. This progress encourages local manufacturing, diminishing reliance on imported medicines and promoting economic development. Furthermore, ML3 NRAs are better equipped to address public health emergencies, enabling swift approvals for vaccines and therapeutics while upholding safety standards. Nonetheless, challenges persist, including fragmented regulatory systems, the prevalence of counterfeit medicines, and limited resources. Overcoming these hurdles necessitates enhanced organizational capacity, investments in training, and the promotion of collaboration among NRAs. There is an urgent call for greater political commitment and resource allocation to strengthen regulatory systems across Africa. Achieving and maintaining ML3 status is essential for enhancing medicine regulation, supporting local manufacturing, and improving public health outcomes across the continent. While progress has been made, sustained efforts are crucial to tackling existing challenges and harnessing the full potential of advanced regulatory frameworks.https://www.mdpi.com/2076-393X/13/6/646regulatory maturitycounterfeit medicineslocal manufacturingpharmacovigilance systememergency preparednesssafety and efficacy |
| spellingShingle | Alemayehu Duga Nebiyu Dereje Mosoka Papa Fallah Tedi Angasa Abebe Genetu Bayih Edinam Agbenu Ngashi Ngongo Raji Tajudeen Jean Kaseya Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products Vaccines regulatory maturity counterfeit medicines local manufacturing pharmacovigilance system emergency preparedness safety and efficacy |
| title | Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products |
| title_full | Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products |
| title_fullStr | Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products |
| title_full_unstemmed | Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products |
| title_short | Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products |
| title_sort | strengthening national regulatory authorities in africa a critical step towards enhancing local manufacturing of vaccines and health products |
| topic | regulatory maturity counterfeit medicines local manufacturing pharmacovigilance system emergency preparedness safety and efficacy |
| url | https://www.mdpi.com/2076-393X/13/6/646 |
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