The international harmonization of human tissue regulation: regulatory control over human tissue use and tissue banking in select countries and the current state of international harmonization efforts

摘要

Human tissues play a critical role in modern medicine, particularly in this era of biotechnology. Beyond immediate therapeutic uses, e.g., transplantation, tissues (unlike organs) may be stored for an indefinite time period in traceable and often coded form and later used for biomedical research purposes, teaching, quality control in healthcare, and the manufacture and production of therapeutic and diagnostic aids. Both living donors and cadavers serve as sources of human tissue.