The promise of a unified African health products regulatory system

One in 10 medical products circulating in low—and middle-income countries (LMICs) is substandard or fake, with the majority in Sub-Saharan Africa being antibacterial and antimalarial drugs. The unchecked spread of these products threatens lives and undermines health care systems already struggling with access and quality.

Even if the drugs are not laced with poison, they may contain actual antibiotics or antivirals, but at a lower dose. This increases the catastrophic threat of antimicrobial-resistant infections that antibiotics won’t be able to treat effectively.

“We reported a 10.5% failure rate on medicine samples in LMICs. What’s more, about US$38.5 million is spent on substandard antimalarials in sub-Saharan Africa. Deaths resulting from fake products are preventable,” said Hiiti Sillo, WHO’s Unit Head of Regulation and Safety.

Patients often receive substandard medical products in settings with insufficient technical capacity and resources to uphold quality standards in the manufacturing, distribution, and supply processes. Consequently, falsified medicines are more prevalent in environments with weak regulatory systems and poor governance. A significant number of incidents reported to the WHO originate from countries facing limited access to medical supplies.

In 2018, Tanzania was the only country in Africa to achieve Maturity Level 3 (ML3) for health product regulation, a significant benchmark set by WHO. By 2024, that number had risen to eight countries, reflecting significant progress in strengthening regulatory systems across the continent.

Achieving ML3 status indicates that a country’s national regulatory authority is stable, well-functioning, integrated and capable of ensuring the safety and quality of medicines, vaccines, blood products, and medical devices. Tanzania, Ghana, Zimbabwe, Senegal, South Africa, Nigeria, Rwanda, and Egypt are the eight African countries which have reached this level of recognition.

WHO evaluates regulatory systems on a scale from 1 to 4. While ML3 denotes a robust and effective system, Maturity Level 4 represents a continued commitment to excellence and innovation. Several African nations are already advancing towards this highest tier.

Ten of the continent’s national health products regulators executives gathered at the inaugural annual forum, held at Wits Business School in March 2025, to participate in a training program intended to strengthen their leadership capacities.

The inaugural training, the African Regulatory Leadership Program (ARLP), galvanizes regulators to safeguard medicines in their own countries and contributes to strengthening a regional regulatory system to facilitate trade and economic opportunities across Africa.

Wits RHI, the Health Regulatory Science Platform (HRSP), and Supporting Health Initiatives (all three are divisions of the Wits Health Consortium), in collaboration with the Harvard T.H. Chan School of Public Health, established the first ARLP training.

ARLP was a recommendation of the Future of Health and Economic Resilience Commission in Africa led by Hon. Muhammad Pate and Dr. Awa Marie Coll Seck, inspired by the Harvard Ministerial Leadership Program. The training had notable faculty members from across the world, with Prof Helen Rees, Wits-RHI Executive Director, and Prof Rifat Atun, the Director of the Health System Innovation Lab at Harvard University, serving as Co-Chairs of the ARLP Steering Committee.

The CEO of the South African Health Products Regulatory Authority (SAHPRA), Dr. Boitumelo Semete-Makokotlela said that the training brought together a range of different agencies across Africa, which all share similar issues of leadership and navigating change.

“The ‘elders’ of health products regulatory systems were all there, and this was what we needed. We have focused a lot on technical capabilities in the past, but we needed to strengthen our leadership to manage the particulars of our national and regional health contexts,” said Semete-Makokotlela.

“We need to be more self-reliant in health care. We already have strong regulatory frameworks in place—now it’s about leveraging them to enhance health product security,” said Precious Matsoso, director of Wits University’s Health Regulatory Science Platform.

Matsoso is also the former Director General of the South African National Department of Health and current co-chair of the WHO Intergovernmental Negotiating Body.

Expert regulatory professionals and other oversight resources for medical products in Africa remain scarce. However, harmonizing efforts, much like the European Medicines Agency has done, are underway on the continent with the establishment of the African Medicines Agency.

One in 10 medical products circulating in low—and middle-income countries (LMICs) is substandard or fake, with the majority in Sub-Saharan Africa being antibacterial and antimalarial drugs. The unchecked spread of these products threatens lives and undermines health care systems already struggling with access and quality.

Even if the drugs are not laced with poison, they may contain actual antibiotics or antivirals, but at a lower dose. This increases the catastrophic threat of antimicrobial-resistant infections that antibiotics won’t be able to treat effectively.

“We reported a 10.5% failure rate on medicine samples in LMICs. What’s more, about US$38.5 million is spent on substandard antimalarials in sub-Saharan Africa. Deaths resulting from fake products are preventable,” said Hiiti Sillo, WHO’s Unit Head of Regulation and Safety.

Patients often receive substandard medical products in settings with insufficient technical capacity and resources to uphold quality standards in the manufacturing, distribution, and supply processes. Consequently, falsified medicines are more prevalent in environments with weak regulatory systems and poor governance. A significant number of incidents reported to the WHO originate from countries facing limited access to medical supplies.

In 2018, Tanzania was the only country in Africa to achieve Maturity Level 3 (ML3) for health product regulation, a significant benchmark set by WHO. By 2024, that number had risen to eight countries, reflecting significant progress in strengthening regulatory systems across the continent.

Achieving ML3 status indicates that a country’s national regulatory authority is stable, well-functioning, integrated and capable of ensuring the safety and quality of medicines, vaccines, blood products, and medical devices. Tanzania, Ghana, Zimbabwe, Senegal, South Africa, Nigeria, Rwanda, and Egypt are the eight African countries which have reached this level of recognition.

WHO evaluates regulatory systems on a scale from 1 to 4. While ML3 denotes a robust and effective system, Maturity Level 4 represents a continued commitment to excellence and innovation. Several African nations are already advancing towards this highest tier.

Ten of the continent’s national health products regulators executives gathered at the inaugural annual forum, held at Wits Business School in March 2025, to participate in a training program intended to strengthen their leadership capacities.

The inaugural training, the African Regulatory Leadership Program (ARLP), galvanizes regulators to safeguard medicines in their own countries and contributes to strengthening a regional regulatory system to facilitate trade and economic opportunities across Africa.

Wits RHI, the Health Regulatory Science Platform (HRSP), and Supporting Health Initiatives (all three are divisions of the Wits Health Consortium), in collaboration with the Harvard T.H. Chan School of Public Health, established the first ARLP training.

ARLP was a recommendation of the Future of Health and Economic Resilience Commission in Africa led by Hon. Muhammad Pate and Dr. Awa Marie Coll Seck, inspired by the Harvard Ministerial Leadership Program. The training had notable faculty members from across the world, with Prof Helen Rees, Wits-RHI Executive Director, and Prof Rifat Atun, the Director of the Health System Innovation Lab at Harvard University, serving as Co-Chairs of the ARLP Steering Committee.

The CEO of the South African Health Products Regulatory Authority (SAHPRA), Dr. Boitumelo Semete-Makokotlela said that the training brought together a range of different agencies across Africa, which all share similar issues of leadership and navigating change.

“The ‘elders’ of health products regulatory systems were all there, and this was what we needed. We have focused a lot on technical capabilities in the past, but we needed to strengthen our leadership to manage the particulars of our national and regional health contexts,” said Semete-Makokotlela.

“We need to be more self-reliant in health care. We already have strong regulatory frameworks in place—now it’s about leveraging them to enhance health product security,” said Precious Matsoso, director of Wits University’s Health Regulatory Science Platform.

Matsoso is also the former Director General of the South African National Department of Health and current co-chair of the WHO Intergovernmental Negotiating Body.

Expert regulatory professionals and other oversight resources for medical products in Africa remain scarce. However, harmonizing efforts, much like the European Medicines Agency has done, are underway on the continent with the establishment of the African Medicines Agency.