Global Health Otherwise, shared on LinkedIn:
“Africa carries a fifth of the world’s population and a large share of global disease, yet the continent hosts just 3% of clinical trials worldwide.
Fragmented regulatory systems have long slowed research and delayed access to safe treatments.
Wiysonge and colleagues (2026) offer a commentary tracing two decades of effort to fix this problem, from the African Vaccine Regulatory Forum launched in 2006 to the African Medicines Agency established in 2021.
The authors show that voluntary, consensus-based reviews collectively cut approval times from a year to about two months, speeding evaluations for vaccines against meningitis, malaria, Ebola, COVID-19, and mpox.
By October 2025, nine African countries had reached WHO maturity level 3, yet the continent still faces more than 100 disease outbreaks a year, demanding faster emergency review pathways.
They argue that lasting progress depends on clear roles for WHO, Africa CDC, and the African Medicines Agency, stronger investment in regulatory workforce and infrastructure, and homegrown oversight of artificial intelligence tools in health products, built on African-led regulatory science.
Two decades of collaborative regulatory reform have accelerated Africa’s clinical trial approvals, but lasting progress now requires stronger governance, sustained investment, and African-led oversight of health technologies including artificial intelligence.”
Title: Strengthening regulation of clinical trials in Africa: a Strategic roadmap for health sovereignty
Authors: Charles S Wiysonge, Patrick D. M. C Katoto, Chinwe Iwu-Jaja, and Glenda E Gray
