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Published on: July 4, 2007
20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms
Gabrielle M O'Sullivan1, Joshua G Philips2, Heidi J Mitchell2
1Research Ethics and Governance Office, Royal Prince Alfred Hospital, Sydney Local Health District, Sydney, NSW, Australia.
Abstract:
•In contrast to the prior voluntary system, since 2001, gene technology in Australia has been regulated under a legislated national Gene Technology Regulatory Scheme which is administered by the Gene Technology Regulator.•The Scheme provides science-based assessment of the potential risks of gene technology to the health and safety of people and the environment.•It complements the role of the Australian Therapeutic Goods Administration which regulates all therapeutic products in Australia to ensure they are safe and effective.•Recent reforms to the Scheme contribute to, and anticipate, the continued safe development and delivery of gene-based human therapeutics in Australia as a successful model for other jurisdictions.
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