Submitted as an open letter to the African Medicines Agency by Yaziid (Kakembo) B.Pharm, Msc. BIRS, AMA.
One strategic area that the African Medicines Agency should consider is the development of a continental bioequivalence support mechanism for African manufacturers. Many local manufacturers are increasingly required to submit bioequivalence data for registration of multisource products, yet access to reliable, affordable and regulatorily acceptable bioequivalence CROs remains limited on the continent. As a result, many manufacturers continue to rely on CROs outside Africa, particularly in Asia and the Middle East, which increases cost, delays product development and limits the growth of Africa’s pharmaceutical ecosystem.
AMA could play a catalytic role by mapping existing and emerging bioequivalence centres in Africa, including those in West, East, Southern and North Africa, and establishing a recognized list of inspected CROs that meet agreed standards for GCP, GLP/GCLP, bioanalytical method validation, pharmacokinetic/statistical analysis, quality management systems, data integrity and computerized systems. This should be supported by joint inspections, reliance on WHO or stringent regulatory authority inspection outcomes, and mutual recognition of AMA/REC/NRA inspection reports.
In addition, AMA could establish a manufacturer support pathway through which African pharmaceutical companies are guided on whether bioequivalence is required, whether a biowaiver may be justified, which African CROs are suitable for the specific product, and how BE study protocols and reports should be submitted for regulatory acceptance across countries. This would reduce duplication, lower costs, support local manufacturing, and increase the availability of quality-assured generic medicines for priority diseases in Africa.
This initiative would align strongly with AMA’s mandate to strengthen regulatory harmonization, support local pharmaceutical production, promote reliance, and improve access to safe, effective and quality-assured medical products across the continent.
Yaziid (Kakembo) B.Pharm, Msc. BIRS
African Medicines Agency