Clinical Trials Down Under

Over the past few years Australia and New Zealand have become a hotspot for overseas companies to conduct clinical trials. The number of Medical device clinical investigations registered with TGA has risen by a steady 7% since 2005.

There are several reasons why companies, especially US sponsors, are going “Down Under” to conduct their clinical trials. Australia possesses an expeditious regulatory approval process known as the Clinical Trial Notification scheme, or CTN scheme.

As the name suggests the CTN scheme is a notification to the Australia regulatory authority, Therapeutic Goods Administration (TGA) that a clinical study is going to commence.

Unlike the US who require FDA approval for most clinical trials via an IND or IDE application, no regulatory submission is required in Australia or New Zealand. Approvals for clinical trials in Australia and New Zealand fall under the jurisdiction of the Institutional Review Board (IRB) or Human Research Ethics Committee (HREC). Once a trial is approved, the CTN form is submitted to the TGA and an acknowledgment letter is providing enabling the legal supply of an unapproved product for a clinical trial.

In addition to the CTN scheme, Australia and New Zealand are English-speaking, boast some of the most experienced best research centers in the world with state of the art facilities, and have a diverse array of key opinion leaders who are extremely experienced in early phase through to late stage clinical research.