The Pharmacy and Poisons Board has signed a Confidentiality Commitment with the US Food and Drug Administration (FDA).
The confidentiality commitment facilitates the exchange of critical information and promotes regulatory harmonisation in the field of medical devices and diagnostics.
The agreement is the first of its kind between the FDA and Africa, marking a historic moment of mutual trust and confidence-building between the two regulatory agencies.
According to PPB CEO Fred Siyoi, the deal highlights PPB's proactive approach to enhancing regulatory standards and fostering international cooperation.
Siyoi and Associate Commissioner for Global Policy and Strategy at the US FDA Mark Abdoo underscored their commitment to regulatory excellence through this collaborative framework.
“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,” Siyoi said.
“This affiliation underscores PPB's commitment to achieving regulatory excellence and leading the African continent in medical device regulation.”
This comes even as the PPB attained official recognition as a Medical Device Single Audit Program (MDSAP) Affiliate Member.
PPB was recognised as an MDSAP affiliate member during the just concluded 25th Session of the International Medical Devices Regulators Forum (IMDRF), held from March 11 to 14, 2024 in Washington.
“Through MDSAP membership, PPB ensures that medical devices and diagnostics entering the Kenyan market meet high-quality, safety and performance standards,” Siyoi said.
This makes the board join a network of regulators including the US FDA, UK-Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
Others include Australia’s Therapeutic Goods Administration (TGA) and Brazil’s The Brazilian Health Regulatory Agency (ANVISA).
As an affiliate member, PPB is now empowered to conduct quality audits for medical devices and diagnostics and manufacturers.
The session centered on the theme of reliance as a cornerstone of collaboration and harmonization in regulatory frameworks for Medical Devices.
According to the FDA, the Medical Device Single Audit Program allows an MDSAP-recognised auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.