Remarkable developments in the scientific, technical and medical fields have led to the increased therapeutic use of human organs, tissues and cells. The use of these substances of human origin (MPHO) in clinical applications has not only saved lives but also improved the quality of life of individuals.  These achievements have resulted, however, in a situation whereby the demand for many MPHO , particularly for organs far outstrips the supply. While the demand for blood components is largely met in developed countries, many developing countries still lack an adequate supply for patients in need of transfusion. In relation to tissues and cells for transplantation and assisted reproduction, the shortages are not as acute and generally patient needs can be met in developed countries, with the possible exception of highly matched hematopoietic stem cells.

In spite of significant benefits derived from therapies using MPHO there is an inherent risk of disease transmission and /or a negative outcome. There are numerous reports in the literature concerning infectious disease, malignancy and other serious adverse occurrences associated with donor to recipient transmissions for all MPHO. The introduction of vigilance and surveillance systems can facilitate the monitoring of severe adverse occurrences and lead to improved measures for dealing with them as has been demonstrated with blood component transfusion and haemovigilance systems.
Recognizing the need for the surveillance of such occurrences, the World Health Assembly (WHA) in May 2010, called on the World Health Organization (WHO) to facilitate inter alia Member States’ access to ‘appropriate information on the donation, processing and transplantation of human cells, tissues and organs, including data on severe adverse events and reactions’.
In accordance with these resolutions, WHO, the Italian National Transplant Centre (CNT) and the EU-funded Project ‘Vigilance and Surveillance of Substances of Human Origin’ (SOHO V&S) joined forces to organize a major global initiative aimed at raising the profile of vigilance and surveillance (V&S) of substances of human origin. The initiative was called Project Notify.