Abstract
Australia has a strong history of medical research. Regulatory mechanisms relating to the conduct of clinical trials were established approximately 30 years ago; since then, the legislation and procedures have undergone a number of changes. Much of the impetus for those changes has come from the medical research community seeking greater involvement in pharmaceutical research and development. The effect of the changes has been a decrease in regulatory agency involvement and a marked increase in the number of clinical trials being conducted. Australia is currently considering its position regarding adoption of the International Conference on Harmonization Good Clinical Practice (ICH GCP) Guideline.
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