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Regulatory Framework * Australia's National Approach to Clinical Trials

The Australian Government is working to enhance the clinical trials industry to maintain Australia’s global competitiveness. The pharmaceutical industry and Australian, State and Territory Governments have joined forces in a Forum on a National Approach to Clinical Trials.

The Forum has identified initiatives to further improve the quality, timeliness, value and capacity of clinical trials in Australia. As a result, the NHMRC is taking the lead to coordinate a nationally harmonised system of scientific and ethics review of multi-centre research in Australia. 

Importation of Material

Typically, a specific import permit is not required for clinical trial material, however, some clinical trial materials may be subjected to additional restrictions and separate approvals may be required (e.g. products containing substances that are listed as prohibited imports and materials of biological origin).

Adherence to GCP Mandatory

Australia has a strong reputation for the quality of its scientific and medical research. In relation to Good Clinical Practice (GCP), the TGA has adopted the European Guideline CPMP/ICH/135/95 (and therefore the ICH E6 guidance) in principle, with some elements modified according to local regulatory requirements. Adherence to ICH GDP is, under Regulation 12AB of the Therapeutic Goods Regulations 1990, mandatory in Australia for trials conducted under either CTN or CTX. 

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