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GUIDELINES FOR THE ESTABLISHMENT AND OPERATION OF PHARMACEUTICAL SCIENTIFIC OFFICES IN KENYA

The regulation of HPTs in Kenya has continued to evolve in response to advances in

pharmaceutical science, the diversification of product categories, and the growing

need for efficient regulatory engagement. As MAHs and LTRs increasingly rely on

specialized technical services for regulatory support, the Board has identified the

need for a structured framework governing such activities.

These Guidelines therefore establish the requirements for the creation and operation

of Pharmaceutical Scientific Offices; non-trading entities authorized to manage

scientific and regulatory affairs on behalf of MAHs and LTRs. The framework ensures

that these offices operate within the boundaries of the Pharmacy and Poisons Act

CAP 244 of the Laws of Kenya and the Pharmacy and Poisons Rules, 2022, while

reinforcing the principle that statutory responsibility for products remains with the

MAH or LTR.

The Guidelines set out the standards for licensing, governance, permitted functions,

and compliance obligations for Scientific Offices. They are intended to enhance

regulatory quality, promote consistency in technical submissions, support informed

scientific dialogue with the Board, and strengthen oversight across the product

lifecycle in the interest of public health.

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