In a bid to enhance medical regulation in the country, Pharmacy and Poisons Board (PPB) has entered into a partnership with the Food and Drug Administration (FDA), through a Confidentiality Commitment that was signed in Washington DC over the weekend.
Speaking during the event, PPB Chief Executive Officer Fred Siyoi and FDA Associate Commissioner for Global Policy and Strategy, Mark Abdoo, expressed commitment to regulatory excellence through the collaborative framework.
They said the collaboration is aimed at enhancing regulatory standards and fostering international cooperation.
The partnership will ensure exchange of critical information and promote regulatory harmonisation in medical devices and diagnostics.
The agreement is the first of its kind between the American agency and an African country.
In a statement, PPB said it values collaboration with members of the International Medical Devices Regulators Forum (IMDRF), including regulatory authorities from the United States, 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 Africa in medical device regulation," said Dr Siyoi.
The 25th Session of the International Medical Devices Regulators Forum, held from March 11 to 14, 2024, was themed, "Reliance as a cornerstone of collaboration and harmonisation in regulatory frameworks for medical devices."
By joining a network of regulators including US Food and Drug Administration, UK-Medicines & Healthcare products Regulatory Agency, Health Canada, Japan's Pharmaceuticals and Medical Devices Agency, Australia's Therapeutic Goods Administration and Brazilian Health Regulatory Agency, the Kenyan regulator is expected to conduct quality audits for medical devices and diagnostics.
Kenya has been grappling with an influx of sub-standard medical products, raising questions over approval and standardisation procedures.