Pharmaceutical regulatory harmonization in Africa: a scoping review of policy design, implementation approaches, and outcomes.

BACKGROUND

Limited capacity in African national medicine regulatory authorities results in delayed registrations, regulatory inefficiencies, and the ongoing circulation of substandard and falsified medicines. The African Medicines Regulatory Harmonization initiative and regional mechanisms work to make medicine approval faster and fairer across Africa using convergent mechanisms. We aim to map and integrate evidence on pharmaceutical regulatory harmonization in Africa, concentrating on policy, implementation strategies, and reported outcomes, and identify barriers, facilitators, and evidence gaps to guide future research and policy formulation.

METHODS

This scoping review applied Arksey and O'Malley's framework (Levac refinements) and PRISMA-ScR reporting standards. Systematic searches of PubMed, Scopus, Web of Science, Embase, and targeted gray literature identified English-language sources addressing policy design, implementation, governance, barriers/facilitators, and outcomes of pharmaceutical regulatory harmonization in Africa. Data from 19 included documents (2015-2025) were charted and synthesized via descriptive summaries and inductive thematic analysis.

RESULTS

The primary strategies included joint reviews, collaboration in Good Manufacturing Practice (GMP) inspections, regulatory reliance, standardized technical guidelines, and partnership-based capacity building. Documented improvements encompassed significant reductions in median joint review durations (e.g., EAC: 553-259 days), elevated application volumes, enhanced adherent GMP rates, improved Global Benchmarking Tool maturity levels, and economically viable regional recommendations. Major barriers were resource limitations, maturity differentials, delayed national uptake, weak binding reliance, coordination inefficiencies, and donor dependency; key facilitators included political will, partner support, International Medicines Regulatory Authority (IMRA) trust, and proven process efficiencies.

CONCLUSION

Regional harmonization has produced significant regulatory efficiency and capability in East and Southern Africa. Regional harmonization has resulted in continued progress toward the Africa Medicine Agency necessities, enhanced political dedication, and diversified funding. Expedited adoption of standardized protocols, reinforced reliance mechanisms, and theory-based longitudinal assessments are needed to ensure equitable and sustainable access to quality pharmaceuticals.