GUIDELINE FOR POST-MARKETING SURVEILLANCE OF HEALTH PRODUCTS AND TECHNOLOGIES IN KENYA

Health products and technologies (HPTs) are essential components of healthcare service delivery. Essential medicines policies are crucial to promoting health and achieving sustainable development goals. Sustainable development goal (SDG) 3.8, specifically mentions the importance of “access to safe, effective, quality and affordable essential medicines and vaccines for all” as a central component of Universal Health Coverage (UHC) and SDG 3.b emphasizes the need to develop medicines to address persistent treatment gaps. Access to good quality HPTs increases public confidence in healthcare systems.

Quality of HPTs is an important factor in disease prevention and treatment. Quality is fundamental to their effectiveness and safety, hence being able to achieve desired patient outcomes. Ensuring quality requires concerted effort by all stakeholders in the entire lifecycle of HPTs. Kenya is a vibrant generic market with a wide variety of registered HPTs. Therefore, good laws, guidance and management processes are required to ensure effective monitoring of quality of medical products and health technologies