US FDA Delegation Strengthens Ties with Kenya's Ministry of Health

Nairobi, Kenya -  On June 20 2024, a delegation from the US Food and Drug Administration (FDA) visited the Ministry of Health, where they were received by Dr. Patrick Amoth, the Acting Director General of Health, on behalf of Health Cabinet Secretary Nakhumicha S. Wafula. 

This visit marks a significant step towards strengthening the collaborative efforts between the Pharmacy and Poisons Board and US FDA regulatory bodies. The Government of Kenya has identified Health Products and Technology as one of the four key pillars of Universal Health Coverage under the Bottom-up Economic Transformation Agenda. 

The other pillars include Human Resource for Health, Healthcare Financing, and Digital Health. To ensure the security of health commodities, Kenya is promoting local manufacturing. 

This initiative includes the establishment of the Kenya Biovax Institute and support for the Pharmacy and Poisons Board (PPB) to achieve WHO Maturity Level 3 (ML3) status as a National Regulatory Authority (NRA). 

Dr. Amoth highlighted that achieving WHO-ML3 status offers significant benefits for both local manufacturers and importers of medical products, including simplified approval processes and enhanced transparency.

“These streamlined regulatory processes will facilitate business and local manufacturing, ensuring efficient market access for commodities and improving access to affordable, cost-effective medical products. Local pharmaceutical manufacturers are particularly supported through tax-free importation of Active Pharmaceutical Ingredients (APIs) and equipment for high-quality medicine production," he said