CLINICAL TRIALS IN AUSTRALIA

Australia has long been the chosen destination for international biotechnology, medical device and pharmaceutical companies wishing to expedite their clinical trial programme. Australia is considered a preferred destination for clinical development programs for various reasons including:

  • World class facilitates and resources;
  • A strong network of global key opinion leaders across therapeutic areas;
  • A simplified regulatory pathway allowing trials to commence is as little as 8 weeks;
  • A competitive exchange rate and reduced labour costs relative to the US and EU markets; and
  • A generous R&D Tax Incentive Scheme that is designed support and encourage clinical trials in Australia.

In addition, data from clinical trials conducted in Australia is recognised by international regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as reliable, accurate and high quality.

Furthermore, in consultation with the Health Departments of various States and Territories, the Australian and New Zealand healthcare industry has developed template clinical trial research agreements (including template indemnity documents). Not only does this reduce uncertainty around the cost of conducting clinical trials in Australia, but it has also streamlined the negotiation of project budgets and assisted international sponsors engage Australian clinical trial sites.

When highly informed patients, a collaborative Government, a strong network of sites and investigators combine with the R&D Tax Incentive Scheme, Australia becomes the preferred destination for organisations to conduct their clinical trial.

AUSTRALIA'S STREAMLINED REGULATORY SYSTEM

In Australia the clinical trial review is conducted by the site Ethics Committee rather than the Therapeutic Goods Administration (TGA), the regulatory body. There is also mutual acceptance of the Ethics Committee decisions across the majority of the states, allowing for further expedition of the process by using a Lead Site for ethic submissions. A Clinical Trial Notification (CTN) form is electronically submitted to the TGA, upon which an acknowledgement for the trial is provided typically within 2-3 days.

Clinical trial sites may be initiated, once ethics committee and site governance approvals are received, and the TGA acknowledges receipt of the CTN form.

 

PARALLEL AND STREAMLINED PROCESS

AUSTRALIAN R&D TAX INCENTIVE SCHEME

The Australian Government offers one of the world’s most generous Research and Development Tax Incentives. Currently the R&D Tax Offset is offered in two streams:

  1. A 43.5% refundable tax offset for eligible entities whose aggregated yearly turnover is less than $20 million. This could result in a 43.5¢ cash refund per $1 of eligible R&D expenditure.
  2. A 38.5% non-fundable tax offset for all other eligible entities. This translates to at least an 8.5¢ permanent after tax benefit per $1 of eligible R&D expenditure.

To be eligible for the R&D Tax Incentive you must meet certain eligibility criteria. Southern Star Research would be happy to provide recommendations on specialist companies that can provide further advice on the specifics of the R&D Tax Incentive and eligibility in relation to clinical trials activities.