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, prolongedapprovals, and delayed medical access. To inform the African Medicines Agency(AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's firstcontinental scientific evaluation of human medicinal products. This study evaluates thepilot's performance and how scientific opinions translated into national decisions. Methods: A mixed-methods evaluation used regulatory datasets from the pilot. Dataincluded assessment timelines, GMP inspections, and national actions. Thematic analysisidentified uptake determinants.Results: Of 64 expressions of interest, 24 progressed to evaluation, and 12 receivedpositive opinions. Ten met the ≤210-day target. Twenty-four GMP inspections founddeficiencies aligned with global standards. National uptake: full reliance for 7 products(58%); sequential reliance for 3 (25%); separate assessment for 2 (17%). Someproducts registered in up to 23 countries within a median of 77 working days postrecommendation.Uptake variability reflected legal authority, administrative requirementsand submission strategies. Conclusions: The pilot shows a continent-wide regulatory mechanism is feasible andcan produce trusted scientific outputs and enable reliance-based national decisionsin Africa. Despite widespread reliance, heterogeneity in procedures and sequencingaffected registration time. These findings provide empirical evidence for AMA scaleup,emphasizing the need for harmonised pathways, streamlined administration anddigital infrastructure.