By Tajeu Shadrack Nkapapa
In a significant move to bolster collaborations, the Pharmacy and Poisons Board (PPB) of Kenya and the United States Food and Drug Administration (US FDA) have signed a Statement of Commitment.
Mark Abdoo, the Associate Director for Global Policy and Strategy at the US FDA, and Dr. Ahmed Mohamed, PPB’s Director of Health Products and Technologies, formalized the agreement on Thursday.
On June 20, Dr. Patrick Amoth, the Acting Director General of Health, on behalf of Health Cabinet Secretary Nakhumicha S. Wafula received a delegation from the US Food and Drug Administration (FDA) who visited the Ministry of Health.
This visit marks a significant step towards strengthening the collaborative efforts between the Pharmacy and Poison Board and US_FDA regulatory bodies.
According to the Ministry of Health, Kenya is actively encouraging domestic production to safeguard the safety of healthcare products.
As part of this effort, the Kenya Biovax Institute has been established and the Pharmacy and Poisons Board (PPB) is being supported to attain the 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,” Dr. Amoth said.
“Local pharmaceutical manufacturers are particularly supported through tax-free importation of Active Pharmaceutical Ingredients (APIs) and equipment for high-quality medicine production,” he added.
The Kenyan government has recognized Health Products and Technology as one of the four main pillars of Universal Health Coverage within the framework of the Bottom-up Economic Transformation Agenda.
The remaining pillars consist of Human Resource for Health, Healthcare Financing, and Digital Health.