Kenya's Pharmacy and Poisons Board signs deal with America's FDA

Kenya’s Pharmacy and Poisons Board (PPB) signed a Confidentiality Commitment with the United States's Food and Drug Administration (FDA) on March 15, 2024, in Washington D.C.

The PPB Chief Executive Officer (CEO), Fred Siyoi, and Mark Abdoo, Associate Commissioner for Global Policy and Strategy at the US FDA, highlighted their commitment to regulatory excellence through the collaborative framework.

In a statement, Siyoi stated that the Confidentiality Commitment facilitates the exchange of critical information and promotes regulatory harmonisation in the medical devices and diagnostics field.

He stated that the PPB recognizes the value of reliance practices and actively collaborates with members of the International Medical Devices Regulators Forum (IMDRF), including regulatory authorities from the US, Singapore, Australia, Canada, Brazil, Japan, the European Union, and South Korea.

“As an affiliate member of the IMDRF, PPB gains access to guidance documents and technical expertise, enabling the acceleration of regulatory processes and the elimination of trade barriers. This affiliation underscores PPB's commitment to achieving regulatory excellence and leading the African continent in medical device regulation,” said Dr. Siyoi.

The PPB’s CEO further stated that joining the Medical Devices Single Audit Program (MDSAP) strengthens its capacity for quality audits of medical device manufacturers, ensuring that medical devices and diagnostics entering the Kenyan market meet high-quality, safety, and performance standards.

“By joining a network of regulators including the U.S. Food and Drug Administration, UK-Medicines & Healthcare Products Regulatory Agency (MHRA), Health Canada, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Australia's Therapeutic Goods Administration (TGA), and Brazilian Health Regulatory Agency (ANVISA), PPB is now empowered to conduct quality audits for medical devices and diagnostics,” he said.