Kenya strengthens ties with US FDA to enhance pharmaceuticals regulations 

Pharmacy and Poisons Board has signed a statement of commitment with US Food and Drug Administration in a significant move to bolster collaborations.

The commitment seeks to strengthen existing structures, explore and develop new opportunities for engagement and enhance capacity in regulatory and public health protection.

Mark Abdoo, the Associate Director for Global Policy and Strategy at the US FDA, and Dr. Ahmed Mohamed, PPB’s Director of Health Products and Technologies, formalized the agreement on Thursday.

This event follows a confidentiality agreement signed between PPB and the US FDA in March 2024, aimed at fostering new opportunities for cooperative engagement in the pharmaceutical sector.

The US FDA delegation also visited the Ministry of Health, where they were received by Dr. Patrick Amoth, the Director General, representing Health Cabinet Secretary Susan Nakhumicha.

Dr. Amoth emphasized the government’s Bottom-up Economic Transformation agenda, highlighting health as a key pillar of Universal Health Coverage.

He highlighted that achieving WHO-ML3 status offers significant benefits for both local manufacturers and importers of medical products, including simplified approval processes and enhanced transparency.

“These streamlined regulatory processes will facilitate business and local manufacturing, ensuring efficient market access for commodities and improving access to affordable, cost-effective medical products. Local pharmaceutical manufacturers are particularly supported through tax-free importation of Active Pharmaceutical Ingredients (APIs) and equipment for high-quality medicine production,” he said.

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