Narrative review reveals severe health risks from substandard and falsified medicines in Africa, highlighting the necessity of strengthening regulatory systems.
Key Points
To synthesize evidence on pharmaceutical regulatory systems, evaluate institutional capacity gaps, and assess the public health consequences of substandard and falsified medicines in Africa.
Conducted a narrative review of peer-reviewed and grey literature published between 2000 and 2025 across PubMed/MEDLINE, Scopus, Web of Science, Google Scholar, and health agency reports.
Identified 633 records and performed full-text evaluations on 122 articles, ultimately including 38 studies that addressed regulatory functions, policy responses, and health impacts.
Regulatory deficits contributed directly to treatment failure, severe drug toxicity, the acceleration of antimicrobial resistance, and unnecessary healthcare spending.
Regulatory maturity remains highly uneven across national agencies, with select authorities reaching World Health Organization Maturity Level 3 while most operate at lower tiers.
Identified strategic interventions including digital monitoring platforms, regional reliance frameworks, World Health Organization prequalification, and operationalization of the African Medicines Agency.