Institutional Biosafety Committee

Gene Technology Legislation in Australia

Commercial use of Genetically Modified Organisms (GMOs) or clinical trials using GMOs classified as GMOs in Australia generally require a licence from the Office of the Gene Technology Regulator (OGTR).

Organisations commercially using GMOs for therapeutic purposes and/ or conducting clinical trials with material classified as GMOs must be accredited with the OGTR to be able to hold the licence in their name.

In Australia, the Gene Technology Act 2000 enables a nationally consistent scheme involving all States and Territories. The Act defines “to deal with”, a GMO, to mean the following:

• Conduct experiments with the GMO;
• Make, develop, produce or manufacture the GMO;
• Breed the GMO;
• Propagate the GMO;
• Use the GMO in the course of manufacture of a thing that is not the GMO;
• Grow, raise or culture the GMO;
• Import the GMO.

Graythan Regulatory Services IBC

GRS has over 30 years of experience with gene technology regulatory submissions. We have set up four IBCs for an Australian Government Department, an Industry group, a Clinical Research Organisation (CRO), and some years ago Graythan Regulatory Services (GRS).  Our team has also accredited 10 organisations under the Act including an Australian Government Department, small and large CROs, an industry group, and large pharmaceutical companies. Our GRS IBC members all have been chairs of IBCs and members of multiple IBCs over the years.

The GRS IBC is accredited with the OGTR and has experience with commercial programs, clinical trials, and current Good Manufacturing Practice (cGMP) manufacturing that falls under Physical Containment (PC)2/ Biological Safety Level (BSL) 2 large-scale requirements. Each committee member has an average of 20-30 years of experience in the pharmaceutical industry. Our Committee includes the following positions/ expertise: