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Regulatory Framework * Gene Technology Regulation

The Commonwealth Gene Technology Act, 2000 took effect on 21 June 2001. It aims to protect the health and safety of people and the environment by identifying and managing risks posed by, or resulting from, genetically modified organisms (GMOs) that result from gene technology.

The Office of the Gene Technology Regulator (OGTR) falls within the control of the TGA and currently employs 50 scientific, legal, professional and administrative staff. Special advisory, ethics and community consultative committees all provide advice to the OGTR. Strict guidelines are set up by the OGTR in relation to clinical trials using GMOs.

To assist sponsors to undertake clinical trials involving GM products, please contact QCTN’s independent IBC.

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