Guideline for Post-marketing Surveillance of Medical Products and Health Technologies in Kenya

Medical products and health technologies (MPHTs) are essential component 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 MPHTs increases public confidence in healthcare systems.

Quality of MPHTs 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 MPHTs. Kenya is a vibrant generic market with a wide variety of registered MPHTs. Therefore, good laws, guidance and management processes are required to ensure effective monitoring of quality of medical products and health technologies