International acceptance of blood and blood products.

ABSTRACT

International agreement on the standardisation of blood and blood products is of crucial importance in helping to ensure that those biological medicines are safe and effective. International efforts to establish norms for the acceptability of biological products are accomplished primarily through the WHO, and many international reference materials needed for calibration, such as standards for blood grouping and hepatitis C virus RNA have been established by WHO. In addition to coordinating the development of physical standards, WHO also has been the major player in attempting to generate an international consensus on the basic criteria for the acceptability of biological products. However, requirements for safe blood and blood products are fluid because new risks or new infectious agents continue to be identified. For all those reasons, worldwide harmonization of the quality of blood and blood products remains an elusive goal. However, opportunities to move forward exist, and WHO is in a good position to act as a catalyst for progress.