USA—The Pharmacy and Poisons Board (PPB) has achieved a significant milestone in regulatory enhancement by establishing a Confidentiality Commitment with the United States Food and Drug Administration (US FDA).

This landmark agreement, signed on March 15th, 2024, in Washington, D.C., follows a week marked by substantial success for PPB in medical device and diagnostics regulation.

The Confidentiality Commitment represents a crucial step towards fostering collaboration between PPB and the US FDA, facilitating the exchange of vital information, and promoting regulatory harmonization in the realm of medical devices and diagnostics.

This development comes on the heels of Dr. Kariuki Gachoki, Deputy Director of the Department of Product Evaluation and Registration at PPB, presenting the application during the Management Committee Closed Session, underscoring PPB’s dedication to enhancing regulatory standards and promoting global cooperation in the medical device sector.

 During the signing ceremony, both Dr. Fred Siyoi, CEO of PPB, and Mr. Mark Abdoo, Associate Commissioner for Global Policy and Strategy at the US FDA, reiterated their shared commitment to regulatory excellence through this collaborative framework.

Furthermore, this signing event closely follows PPB’s official recognition as an MDSAP Affiliate Member for the Medical Devices Single Audit Program (MDSAP).

Joining the International Medical Device Regulators Forum (IMDRF) as an affiliate member opens doors to invaluable learning and collaboration opportunities with regulatory bodies worldwide.

IMDRF has representatives from regulatory authorities in Australia, Brazil, Canada, China, the European Union, Japan, Singapore, South Korea, the United Kingdom, and the United States.

MDSAP serves to minimize the number of audits necessary by several regulatory bodies to certify a manufacturer’s ongoing compliance with the quality management system (QMS) standards of each MDSAP regulatory agency, thus saving time and eliminating disruptions to manufacturing operations.

Moreover, other advantages of MDSAP include increased acceptance of audit reports by participating authorities and more transparent and consistent oversight by regulators, including follow-up on audit findings.

Regulatory authorities can utilize MDSAP audit reports to analyze specific regulatory approval applications and incident reports, enhancing overall regulatory efficiency and effectiveness.

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