An activity-based costing analysis of the Continental Listing Pilot Study: lessons for the operationalisation of the African Medicines Agency

Aims. The African Medicines Regulatory Harmonisation (AMRH) Continental Listing Pilot tested a coordinated continental procedure for evaluating human medicinal products in Africa; however, its operating cost was unknown. This study aimed to quantify the pilot's cost structure, identify principal cost drivers and generate empirical evidence to inform future costing and fee design under the African Medicines Agency (AMA). Methods. An activity-based costing analysis was undertaken. Operational and financial records from the AMRH Secretariat, Evaluation of Medicinal Products Technical Committee (EMP-TC), and Good Manufacturing Practices Technical Committee (GMP-TC) were mapped to workflow activities and classified by cost behaviour and attribution. Scenario, sensitivity and benchmarking analyses were conducted. Results. The monetized baseline was USD 1,771,149: inspection and compliance USD 676,665 (38.2%), scientific assessment USD 561,716 (31.7%) and Secretariat coordination USD 532,767 (30.1%). Costs were predominantly variable (89.7%), with direct and indirect costs at near parity (52.2% and 47.8%). Direct reviewer remuneration accounted for 19.8% of the EMP-TC envelope, compared with 43.7% for deliberation infrastructure. A single bundled onsite inspection deployment represented 23.4% of the total baseline. Governance-linked expenditure behaved as step costs tied to review cycles rather than dossier volume. Conclusions. Continental medicines evaluation is governance-intensive, with costs scaling non-linearly with throughput. Sustainable AMA cost recovery will require fee structures distributing cycle-based costs across applications and incorporating risk-based, reliance-informed inspection strategies. The baseline excludes digital infrastructure, in-kind expert participation, hosting, licensing, cybersecurity, eCTD platforms, office and utility costs and partner-supported technical inputs