ADVOKS GLOBAL · KENYA
Charter for Kenya Medical Research Institute, 2026
42. Assessment of quality, efficacy, and safety
Edition: 2025-07-21 · In force
42. Assessment of quality, efficacy, and safety
(1)The Institute shall, upon reference, in collaboration with relevant agencies conduct comprehensive assessments of traditional and alternative medicinal products to determine their quality, efficacy and safety for purposes of safeguarding public health.(2)The Institute, in conducting the assessments in subparagraph (1)—(a)shall focus on utilizing Kenya's biodiversity and in particular, indigenous flora for the discovery of novel medicinal properties;(b)shall employ a variety of scientific methodologies including biochemical, pharmacological and toxicological evaluations;(c)may conduct preclinical and clinical trials to assess the safety and efficacy of traditional and alternative medicinal products; and(d)shall oversight the standardization and validation of traditional and alternative medicinal products.(3)The Institute shall support the relevant regulatory bodies to establish and enforce quality assurance standards and conduct market surveillance to ensure—(a)that traditional and alternative medicinal products are safe, efficacious and of high quality; and(b)the proper labeling, advertising and marketing of traditional and alternative medicinal products to prevent misleading representation.(4)The Institute shall—(a)identify high-potential healthcare products derived from traditional and natural sources and support their development into scalable prototypes;(b)authenticate natural medicinal products and promote sustainable conservation of their sources; and(c)provide traditional medicine practitioners and herbal product developers with the necessary support and guidance.(5)The Institute may, in the discharge of the duties in subparagraph (1), establish a framework for the identification and support of healthcare products derived from traditional and natural sources with significant potential for contribution to the health sector.(6)The framework in subparagraph (2) shall—(a)make provision for the criteria for the evaluation of healthcare products based on their safety, efficacy, sustainability and capacity to address unmet healthcare needs;(b)require the Institute to lead research initiatives for the investigation of extracts, fractions and compounds derived from natural products for their potential therapeutic applications in disease management;(c)facilitate the development of healthcare products into scalable prototypes through providing the necessary technical, scientific and regulatory assistance; and(d)support for development.