Abstract 

The issue of substandard and falsified (SF) medical products poses a major challenge to pharmaceutical quality assurance and public health in Africa, where such medicines undermine treatment effectiveness and patient safety. The World Health Organization (WHO) estimates that up to 10% of medicines in low- and middle-income countries may be falsified, with Africa bearing a large share of this burden.1 While discussions often focus on regulatory gaps and supply chain problems, they tend to overlook enforcement difficulties, informal distribution channels and the limits of current detection methods.

This article fills these gaps by offering a thorough review of the regulatory, economic and supply chain factors that sustain SF medicines and suggests practical interventions. Using a variety of global health reports, regulatory frameworks and case examples from sub-Saharan Africa, it analyses the impact of weak regulation, poor enforcement, limited technology and insufficient pharmacovigilance. The article emphasises that strengthening regulatory systems through risk-based surveillance, adopting innovative detection tools and fostering international cooperation are vital steps to reduce the prevalence of SF medical products. Its goal is to provide regulatory professionals with insights and strategies to tackle the challenges of SF medicines, highlighting actionable ways to improve medication quality and public health in Africa.