Leadership training empowers Africa’s health regulators
- Wits University
The new African Regulatory Leadership Programme (ARLP) is a step towards regional harmonising and establishing the African Medicines Agency.
Held at the Wits Business School, the continent’s top national health products regulators gathered in Johannesburg last week to advance their leadership skills and mutually map out how Africa can strengthen its regulatory capacity. This comes at a critical juncture in light of global funding cuts and the prevalence of substandard and falsified medicines.
Professor Helen Rees, CEO of Wits RHI, highlighted the importance of African regulators in ensuring regional and national health product safety. “A new generation of regulatory leaders are now contributing to regional harmonisation efforts and supporting the establishment of the African Medicines Agency. The focus until now has been on technical milestones, but we recognised the need for the personal growth of these regulatory leaders, hence the establishment of the ARLP.”
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, inspired by the Harvard Ministerial Leadership Programme.
A significant leap in regulatory maturity levels
In 2018, only one country, Tanzania, had achieved maturity level 3 (ML3) in terms of health products regulation. In 2024, eight African countries had achieved this, meaning that their national health regulator was stable, well-functioning, and integrated. The World Health Organization (WHO) benchmarks the regulatory systems of a variety of product types, including medicines, vaccines, blood products and medical devices.
Ghana, Zimbabwe, Senegal, South Africa, Tanzania, Nigeria, Rwanda and Egypt have achieved ML3 status. (The highest attainment is ML4, which signifies an ongoing commitment to maintain an already advanced regulatory system. Several African countries are already on the path to achieving this.)
“ML3 is only achieved by a few countries globally and highlights that more African countries can be awarded this. Moreover, the ARLP can encourage those already at ML3 status to become WHO-listed authorities for certain product streams, like medicines or vaccines, and regulatory functions,” said Hiiti Silo, the Unit Head of Regulation and Safety at the WHO and a member of the ARLP’s teaching and mentorship faculty.
Collaboration: The key to a stronger regulatory future
ARLP faculty member and Principal Policy Specialist at the Africa Union Development Agency (AUDA-NEPAD), Chimwemwe Chamdimba, says that achieving MLs 3 and 4 requires reliance and collaboration. “It’s why we gathered many national regulatory authorities (NRAs) in one room. We need a cadre of experts who have the leadership skills to promote regulatory harmonisation, convergence, networking, and work sharing. We can’t do this alone.”
Emer Cooke, sharing her experience as the Executive Director of the European Medicines Agency, noted that no matter the differences