African regulators are pushing to connect existing medicine-safety systems across the continent so that safety concerns identified in one country can be quickly shared with others.
The proposal was made during the Africa Patient Safety Summit in Kigali, Rwanda on Wednesday, September 16, which brought together government officials, regulatory authorities, healthcare institutions, industry, researchers, innovators and development partners to discuss ways to improve the safety of medicines and healthcare across Africa.
The two-day summit was organised by Medicines for Africa in partnership with the African Medicines Agency (AMA), the African Union regulatory body based in Kigali.
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Delese Mimi Darko, Director General of AMA, said the agency’s role is to connect existing regulatory expertise and systems rather than replace national regulators.
“Our task as AMA is to connect the expertise that already exists into a system that is stronger than the sum of the individual parts,” she said.
Darko said the proposed system would allow countries to share information through harmonised pharmacovigilance, medicine-safety and quality-monitoring systems.
“In case there’s something that any country has to look out for, they can do it through a harmonised pharmacovigilance system, medicine safety system and through one quality monitoring system.”
She said the need for such coordination is linked to the speed at which medicines can move across African borders.
“When a product is registered in one country, the risk of it moving across our porous borders is very, very fast, whether it is registered in those countries or not,” she added.
Darko said a safety finding in one country should therefore be able to serve as a warning to patients and regulators elsewhere.
The proposed system would cover adverse events, therapeutic failure and substandard or falsified medicines, allowing information from one country to be shared with others that may need to take action.
The call comes after AMA took over the African Medicines Regulatory Harmonisation initiative from the African Union Development Agency-NEPAD (AUDA-NEPAD) in January this year, along with the African Union Smart Safety Surveillance programme.
Recent medicine-related incidents have also exposed gaps in safety monitoring. In 2022, the Gambia experienced an outbreak of acute kidney injury among children linked to contaminated cough syrups. WHO said 78 cases were reported between July and September that year, including 66 confirmed deaths.
Laboratory investigations identified four contaminated cough syrups containing unacceptable levels of diethylene glycol and ethylene glycol. The medicines were subsequently recalled.
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Raymond Muganga, Acting Director General of the Rwanda Food and Drugs Authority (Rwanda FDA), said African countries need to strengthen monitoring once medicines reach the market and act quickly when safety concerns emerge.
“We also need to closely monitor medicines once they reach the market, strengthen pharmacovigilance and ensure that any safety concerns are identified and acted upon quickly,” Muganga said.
Kimmo Makinen, co-founder and chief operating officer of Medicines for Africa, said regulatory capacity across the continent has improved in recent years.
He said the number of African regulatory authorities recognised by WHO as reaching Maturity Level 3 has risen to 10.
Mozambique became the 10th African country to reach the level in August 2026, joining Egypt, Ethiopia, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe.
“One thing that countries want to do more and will be doing more is regulatory information sharing to find those synergies,” Makinen said.
“So, if something happens in one country, it will be then known by other countries straight away and they can take action,” he said.
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