Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations.
AIMS Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products. This stud...