The Office of the Gene Technology Regulator was established within the Australian Government Department of Health and Ageing to provide administrative support to the Gene Technology Regulator in the performance of his functions under the Gene Technology Act 2000.

The Gene Technology Act 2000 came into force on 21 June 2001 as a national scheme for the regulation of genetically modified organisms in Australia. It aims to protect the health and safety of Australians and the Australian environment by identifying risks posed by or resulting from gene technology, and to manage those risks through the regulation of dealings with genetically modified organisms.