Analysis of regulatory review models and approval timelines across selected African medicines regulatory authorities using the OpERA framework (2020–2024)

BACKGROUND: The World Health Organization (WHO) developed the Global Benchmarking Tool (GBT) to assess national regulatory systems and support regulatory-system strengthening across regulatory functions. Several African National Medicines Regulatory Authorities (NMRAs) have achieved Maturity Level 3 (ML3). This study aimed to compare regulatory review models for medicines, approval timelines for applications for marketing authorisation of medicines and regulatory practices across four African NMRAs and explore how reported approval timelines and selected practices varied according to WHO maturity-level status. METHOD: The Optimising Efficiency in Regulatory Agencies questionnaire was used in the study. The primary analysis focused on contextual trend analysis of overall approval median timelines for products from 2020 to 2024 for new active substances (NASs), biologicals, vaccines, biosimilars and generic products together with product characteristics. The timelines were summarized using medians, IQRs and sample sizes. Descriptive analyses were conducted across the NMRAs. RESULTS: Approval timelines varied substantially across agencies and product categories. The review of median approval timelines for NASs in 2024 demonstrated that Ghana FDA reported the shortest median approval timelines of 70 calendar days (IQR 25 to 120, n = 30); followed by MCAZ with 603 calendar days (n = 3) then SAHPRA with 628 calendar days (IQR 416 to 937, n = 12) and ZAMRA reported 1242 calendar days (n = 3). CONCLUSION: From this study, it was observed that Ghana FDA has shorter median approval timelines throughout the period under review as compared with the other NMRAs. The findings suggest that evaluation of regulatory processes may assist NMRAs in identifying operational practices associated with improved efficiency.