Activities relating to safety in transplantation cover the safety of the recipient patient and therefore the fulfilment of safety requirements for material of human origin, as well as the safety of the live donor in the short term and the long term. Safety in transplantation is a prerequisite to ensuring ethics in transplantation. Transplantation safety requires proactive approaches such as implementing and maintaining standards for transplantation activities and material for transplantation. It also requires rigorous surveillance of the outcome and adverse events in recipients and live donors and the ability to react to newly identified threats. This is particularly important for recipients of xenotransplantation, where risks are more difficult to predict. Activities aimed at increasing global harmonization and helping Member States to improve safety in transplantation will follow the adoption by the 57th World Health Assembly of a resolution requesting action from WHO on the topic of human transplantation.