South Africa has launched its National Action Plan (NAP) to combat the growing threat of substandard and falsified medical products, a critical move to safeguard public health and strengthen regulatory systems across the country. Introduced on 30 September 2025 by the South African Health Products Regulatory Authority (SAHPRA), in partnership with the National Department of Health and the World Health Organization (WHO), the plan marks a milestone in ensuring access to safe and effective medicines. WHO reports that one in ten medical products in low- and middle-income countries is either substandard or falsified, resulting in widespread treatment failures, preventable deaths, and an estimated global economic loss of US$ 30.5 billion annually.
The NAP is built on three pillars—prevention, detection, and response—designed to protect South Africans from falsified and poor-quality medicines that often mimic essential drugs for HIV, tuberculosis, and other chronic diseases. Guided by WHO’s draft Handbook on the Prevention, Detection, and Response to Substandard and Falsified Medical Products, the plan emphasizes border control, supply chain monitoring, and strong enforcement measures. It also promotes collaboration across regulatory authorities in Africa to harmonize standards and share best practices.
According to SAHPRA CEO Dr. Boitumelo Semete-Makokotlela, the NAP represents a united effort to protect communities, ensuring that everyone—from rural clinics to urban hospitals—has access to trusted medicines. The initiative also empowers communities to report unsafe products, transforming citizens into active participants in safeguarding health.
The official launch in Johannesburg brought together government officials, industry leaders, law enforcement, civil society, and international health partners. Minister of Health Dr. Aaron Motsoaledi highlighted that the issue of fake medicines disproportionately affects the poor and emphasized the need for collective action. He noted that success depends on joint efforts across sectors to protect every life in South Africa and across the continent.
WHO Country Representative Ms. Shenaaz El-Halabi praised the initiative as a model for regional cooperation, underscoring its role in restoring public trust and ensuring the safety and efficacy of medical products. WHO played a key role in supporting the development of the plan, aligning it with international standards and providing technical and strategic guidance at global, regional, and national levels.
Mr. Hiiti Sillo from WHO headquarters commended South Africa’s leadership in piloting the WHO handbook and setting a global example of effective collaboration. He noted that the NAP represents a commitment to patient safety and serves as an inspiration for other countries to strengthen regulatory systems.
Ultimately, South Africa’s NAP is not just a national milestone but a blueprint for the continent, paving the way for stronger regulatory resilience and universal access to safe, effective, and quality-assured medical products across Africa.
