A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

Abstract

AIM: The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision-making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO-GCF), a university-certified short course, Dossier assessment for clinical assessors in Africa, was created to improve regulatory competencies and capacity in dossier evaluation to bridge this gap. METHOD: The 14-week curriculum comprised distance learning approaches including pre-recorded lectures, live virtual sessions, case studies and team projects on the review of regulatory case studies. Covering regulatory decision-making, benefit-risk assessment and critical review of clinical trial data, the course material covered innovator medications in addition to generics and biosimilars. The faculty included international and regional volunteer subject matter experts. RESULTS: Over five cohorts (2022-2026), 197 regulatory scientists drawn primarily from 11 NRAs and a smaller number from the private sector and academia across Africa enrolled in the programme. Outcome data are reported for all cohorts, including the most recent 2026 cohort. Course completion rates improved from 84% (2022) to 100% (2026). Introduced in 2023, the train-the-trainer concept included course alumni as faculty in the programme, therefore strengthening sustained capacity development. However, postcourse evaluations indicated that mentorship and institutional support remain critical for long-term competency retention. CONCLUSION: This 14-week course has enhanced regulatory capacity in Africa and is expected to contribute to improved regulatory decision-making and, indirectly, to enhanced patient access to appropriately assessed medicines. Future versions will concentrate on increasing formal mentoring programmes and improving practical learning opportunities.