Substandard and Falsified Medicines, Regulatory Capacity and Public Health: A Narrative Review With a Focus on Africa

Weak medicines regulation contributes to the circulation of substandard and falsified medicines, undermining treatment outcomes, accelerating antimicrobial resistance and eroding public trust in health systems. This review synthesised evidence on regulatory structures and functions, mapped regional capacity, documented the public health consequences of regulatory failure and identified pathways toward stronger and more equitable pharmaceutical governance in Africa.

This narrative review synthesised peer-reviewed and grey literature published between 2000 and 2025. Sources were identified through PubMed/MEDLINE, Scopus, Web of Science, Google Scholar and institutional reports from the World Health Organisation (WHO), World Bank, African Union Development Agency New Partnership for Africa's Development (AUDA-NEPAD) and national regulatory authorities. Studies were eligible if they addressed regulatory functions, the consequences of substandard and falsified medicines, WHO Global Benchmarking Tool (GBT) maturity assessments, regional harmonisation initiatives or policy responses. The search yielded 633 records, of which 122 underwent full‑text review, and 38 met the inclusion criteria. Evidence was organised thematically across regulatory functions, capacity gaps, pathways of harm, documented incidents and regulatory strengthening initiatives.

Evidence shows that regulatory weaknesses affect public health through therapeutic failure, toxicity, antimicrobial resistance, avoidable expenditure and inequitable exposure among vulnerable populations. African regulatory systems show substantial heterogeneity, with some authorities achieving the WHO GBT Maturity Level 3, whereas many remain at lower maturity levels. Recent advances include digital regulatory platforms, reliance mechanisms, regional harmonisation, WHO prequalification and the establishment of the African Medicines Agency.

Strengthening national regulatory authorities to WHO GBT Maturity Level 3 and above requires sustained political commitment, predictable financing, legal reform, robust post‑market surveillance, accredited laboratory capacity and effective regional reliance mechanisms. Medicines regulation should be recognised as a core public health and health‑security priority, serving as a foundational investment in protecting populations and ensuring equitable access to quality‑assured medicines.