Recipient organisationAfrican Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD)
Funding£9.6M
PeriodSept 2023 — Aug 2028
In plain English
AI plain-English summary
Across Africa, national medicine regulators are too often understaffed, underfunded, or legally unable to approve safe drugs quickly—leaving patients without treatments for preventable diseases. This project tackles that bottleneck by strengthening the regulatory systems themselves, rather than developing new medicines. It supports the African Medicines Regulatory Harmonisation programme, which has already led to the creation of the African Medicines Agency (AMA). The goal is to align technical standards, streamline approval processes, and build institutional capacity so that a drug approved in one African country can be more easily accepted in others. If successful, the work could shorten the time it takes for quality-assured vaccines, antibiotics, and diagnostics to reach clinics across the continent. That would mean fewer deaths from treatable infections and a stronger public health response to both communicable and non-communicable diseases. The project is not about discovering a new molecule—it is about fixing the infrastructure that decides whether existing, life-saving products ever reach the people who need them.
View original technical description
Access to quality-assured, safe and efficacious medical products for the prevention, detection and treatment of diseases is an essential component of any public health system. However, despite Africa's high disease burden and mortality from preventable and curable diseases, unavailability and unaffordability of good quality, safe and efficacious medical products cripple the health system response for both communicable and non-communicable diseases. National Regulation Authorities (NRAs) are essential for unblocking bottlenecks to timely access for the needed medical products and technologies. The African Medicines Regulatory Harmonization (AMRH) programme was initiated in 2009 to support countries to address challenges faced in regulatory systems including limited human and institutional capacity, lack of comprehensive legal frameworks giving a mandate to the governments to regulate medical products and technologies, inconsistent regulatory processes, and variable technical standards and guidelines that do not meet international standards. The progress of the AMRH led to the establishment of the African Medicines Agency (AMA) which will be anchored by regional regulatory harmonization activities. This project is therefore aimed at strengthening regulatory systems and harmonization in Africa for improved access to quality, safe and efficacious medical products by strengthening regional regulatory harmonization and supporting the operationalization of the AMA.
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