Washington DC – Kenya’s Pharmacy and Poisons Board (PPB) has achieved a significant milestone in regulatory collaboration by formalizing a strategic partnership with the US Food and Drug Administration (FDA).

The partnership, symbolized by the signing of a Confidentiality Commitment on March 15th, 2024, in Washington D.C., follows a week of remarkable progress for PPB in regulating Medical Devices and Diagnostics.

Dr. Fred Siyoi, CEO of PPB, and Mr. Mark Abdoo, Associate Commissioner for Global Policy and Strategy at the US FDA, reaffirmed their commitment to regulatory excellence through this collaborative framework. This engagement highlights PPB’s proactive stance in enhancing regulatory standards and fostering international cooperation.

The Confidentiality Commitment signifies a pivotal step towards establishing a collaborative framework between PPB and the US FDA, facilitating the exchange of critical information and promoting regulatory harmonization in the field of medical devices and diagnostics.

This landmark agreement marks the first of its kind between the FDA and a jurisdiction in Africa, signifying a historic moment of mutual trust and confidence-building between the two regulatory agencies.

Recognizing the value of reliance practices, PPB 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.

The recent 25th Session of the IMDRF, held from March 11th to 14th, 2024, emphasized reliance as a cornerstone of collaboration and harmonization in regulatory frameworks for Medical Devices.

Dr. Siyoi emphasized, “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.”

Additionally, PPB’s approval to join the Medical Devices Single Audit Program (MDSAP) strengthens its capacity for quality audits of medical device manufacturers. Through MDSAP membership, PPB ensures that medical devices and diagnostics entering the Kenyan market meet high-quality, safety, and performance standards.

By joining a network of regulators, including the FDA, 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 empowered to conduct quality audits for medical devices and diagnostics.

PPB’s engagement in strategic partnerships and reliance practices underscores its dedication to regulatory convergence and the advancement of public health initiatives in Kenya and beyond.