Op-Ed: Harmonization Without Borders? Why Module 1 Is the Silent Killer of Africa’s Medicines Access Agenda

Africa has crossed a critical threshold.

Thanks to the African Medicines Regulatory Harmonization (AMRH) initiative and the establishment of the African Medicines Agency (AMA), the adoption of the Common Technical Document (CTD) format has transformed how we evaluate the science of medicines across the continent.

For the first time, manufacturers are no longer reinventing the technical wheel for every country. That is real progress. That is worth celebrating.

But we now face an uncomfortable truth: We have harmonized the science (Modules 2–5) but left the administration (Module 1) in a state of fragmentation. And that fragmentation has become the single biggest bottleneck in registering products across African markets.