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.

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. However, whether procured from a living or deceased donor, subjected to sophisticated tissue engineering or used in transplantation in its unprocessed, basic form, human tissue is no longer limited by national borders. Keeping pace with the globalization of the marketplace, the increasingly international scope of human tissue use presents new challenges in cross-border disease control. In response, the regulatory authorities of several industrialized countries, along with consumer and industry leaders