Operationalisation of the African Medicines Agency: Retrospective evaluation of the continental centralised pilot procedure - timelines to recommendation and national registration decisions

BackgroundRegulatory inconsistency across African countries contributes to duplicative scientific assessments, prolonged approval timelines, and delayed access to essential medical products. To inform the operationalisation of the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) programme implemented Africas first continental pilot study for the scientific evaluation and listing of human medicinal products. This study evaluates the pilots procedural performance and examines how continental scientific opinions were translated into national regulatory decisions through reliance mechanisms. Methods and FindingsA mixed-methods programme evaluation was conducted using regulatory datasets generated during the pilot study. Quantitative data included assessment timelines, GMP inspection outcomes and national post-listing regulatory actions. Qualitative thematic analysis was applied to governance documents and National Regulatory Authority (NRA) feedback to identify legal, institutional and procedural determinants influencing uptake. Of 64 expressions of interest, 24 products progressed to full evaluation and 12 received positive continental scientific opinions. Ten met the predefined performance target of [≤]210 working days. Twenty-four GMP inspections identified no critical deficiencies and aligned with global regulatory benchmarks. National uptake demonstrated active reliance: full reliance (continental opinion as primary basis for national approval) for 7 products (58%); sequential reliance (continental assessment supplemented with targeted national queries) for 3 products (25%); and supplemented national review (separate national assessment undertaken) for 2 products (17%). Products with broader market strategies achieved registration in up to 23 African countries within a median of 77 working days post-listing. Variability in uptake reflected national legal authority, administrative requirements, and applicant submission strategies ConclusionsThe pilot study demonstrates the feasibility of a continent-wide regulatory assessment mechanism capable of producing trusted scientific outputs and enabling reliance-based national decision-making in Africa. While reliance was widely applied, heterogeneity in national procedures and administrative sequencing affected time to national registration. Findings provide empirical evidence to inform the AMA scale-up, highlighting the need for harmonised reliance pathways, streamlined administrative processes, and coordinated digital regulatory infrastructure. Author SummaryWhy Was This Study Done? Access to essential, safe, and effective medicines in Africa is often delayed because regulatory systems across countries work independently and have different capacities. To strengthen regulatory efficiency, African institutions have established the African Medicines Agency (AMA) which will carry out continent-wide scientific assessments that countries can rely on when making their own regulatory decisions. However, since no evidence previously existed to show whether such a continental process could work in practice, there was a need to carry out such a study. What Did the Researchers Do and Find? Africas first pilot study of a continent-wide regulatory assessment process for human medicines was evaluated. Of 24 eligible applications, 12 products were listed following a positive scientific opinion issued after scientific assessment and manufacturing quality evaluation. Sixteen national regulatory authorities used the continental assessments directly when granting marketing authorisations, reducing duplication and accelerating decision-making. Countries varied in how quickly and extensively they adopted the continental recommendations, depending on national laws, administrative procedures and capacity. What Do These Findings Mean? A continental assessment system is feasible in Africa that can provide the basis for reliance-based national decisions. To make this approach fully effective under the African Medicines Agency, countries will need clearer reliance legislations and pathways, streamlined administrative processes, and systems that connect continental, regional and national regulatory procedures.