Oluwatobi Adu 
ABUJA, Nigeria – Africa CDC introduces stringent conditions governing vaccine clinical trials across the continent, reinforcing ethics, safety and national ownership.
The new guidance, published on the agency’s website on Thursday, states that no trial can proceed without formal approval from a National Medicines Regulatory Authority. “No NMRA approval equals an illegal trial,” the framework warns.
Sponsors must submit full safety data, manufacturing details and monitoring plans. Ethics approval is mandatory at both national and institutional levels, with emphasis on informed consent, cultural sensitivity and protection of vulnerable populations.
Africa CDC also expands government oversight, requiring alignment with national health priorities and legally binding agreements covering indemnity, insurance and compensation for trial-related harm.
Local leadership is central to the framework. Sponsors must partner with African principal investigators, universities and research institutes, while investing in training, laboratories and technology transfer.
Data sovereignty forms a core pillar. Trial sponsors must clarify data ownership, storage and access, while committing to community engagement and transparent safety reporting.
Crucially, Africa CDC mandates post-trial obligations, including access to successful vaccines, affordable pricing and feedback of results to participants and governments.
Health experts say the guidance marks a shift from passive participation to assertive governance of medical research, positioning Africa as an equal partner rather than a testing ground.
About the Author
Edino Chubiyo Cornelius 
Hussaini Ibrahim 