Abstract
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 study evaluates the pilot's performance and how scientific opinions translated into national decisions.
Methods
A mixed‐methods evaluation used regulatory datasets from the pilot. Data included assessment timelines, GMP inspections, and national actions. Thematic analysis identified uptake determinants.
Results
Of 64 expressions of interest, 24 progressed to evaluation, and 12 received positive opinions. Ten met the ≤210‐day target. Twenty‐four GMP inspections found deficiencies aligned with global standards. National uptake: full reliance for 7 products (58%); sequential reliance for 3 (25%); separate assessment for 2 (17%). Some products registered in up to 23 countries within a median of 77 working days post‐recommendation. Uptake variability reflected legal authority, administrative requirements and submission strategies.
Conclusions
The pilot shows a continent‐wide regulatory mechanism is feasible and can produce trusted scientific outputs and enable reliance‐based national decisions in Africa. Despite widespread reliance, heterogeneity in procedures and sequencing affected registration time. These findings provide empirical evidence for AMA scale‐up, emphasizing the need for harmonised pathways, streamlined administration and digital infrastructure.