What constitutes the current regulatory framework for cells, tissues and organs?
The Food and Drugs Act is the legislation which provides Health Canada with authority over the safety of cells, tissues, and organs intended for transplantation. Currently, under the Food and Drugs Act, some human tissues are being regulated as biological drugs under the Food and Drug Regulations while others are regulated as medical devices under the Medical Devices Regulations. There are no specific regulations for other tissues (e.g., skin, eye, cornea) and organs (kidney, heart, liver, lung). In January 2003, Health Canada issued a Directive and Guidance Document to all establishments and individuals in Canada that are handling and/or processing human cells, tissues, and organs. The documents issued are intended to advise these establishments and individuals of the importance of adhering to basic standards of safety with respect to the manufacture and use of these products. The basic safety standards are stated in the Guidance Document. In late February 2003, a National Review of t
