Regulatory Aspects

The Australian clinical regulatory system is renowned for being fast, fair and accommodating.

The system works through an acknowledgment by the Therapeutic Goods Administration (TGA) known as the Clinical Trial Notification (CTN) scheme.  The majority of trials undertaken in Australia fall under the CTN scheme.

A very small number of trials fall under the Clinical Trial Exemption Scheme (CTX) scheme (similar to a condensed IND application).

As Neuroscience Trials Australia is a registered enterprise with the Therapeutic Goods Administration, we are able to act as the Australian sponsor for customers who do not have a legal entity within Australia.

The sponsor takes overall responsibility for the conduct of the trial and signs either the CTN form or the CTX form.