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Guidance document on submission of documentation for registration of anti-snake venoms

Kenya is home to a wide variety of venomous snake species, many of which pose significant medical risks due to the potent effects of their venom. Out of the 140 identified snake species in Kenya, 29 are venomous, with 13 species being medically significant. These venomous snakes can cause severe injuries or fatalities if not treated promptly, and nine of these species require immediate medical intervention following a bite. To address the public health threat posed by snake envenomations, the Pharmacy and Poisons Board (PPB) is responsible for regulating the registration, importation, and use of snake antivenoms in Kenya.

Antivenoms are essential medicinal products used for the treatment of snake-bite envenoming, and their regulation is crucial to ensure public safety. Under the mandate of Cap 244, the PPB establishes a guidance document for the approval of antivenoms, which includes rigorous requirements for administrative and product information, clinical and preclinical studies, and environmental risk assessments. This guidance document applies specifically to antivenoms and outlines the process for submission, evaluation, and approval. As a key objective, the PPB aims to provide clear, detailed instructions for manufacturers to prepare a comprehensive dossier for antivenom registration, including product specifications, clinical trial data, and post-market surveillance commitments. This framework supports the development of safe and effective antivenoms, addressing the critical need for timely, region-specific treatments to combat venomous snakebites across Kenya.

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