Why Australia is the Go-to Country for Conducting Clinical Trials

The facilities provided in Australia for your trial are amongst the best in the world, with state-of-the-art facilities, and assisted by the Australian Government’s continuous investment in infrastructure and research. The trial facilities are specially commissioned to deliver challenging first-in-human trials. Outcomes generated using these facilities provides confidence to Regulatory Authorities.

Australia offers biopharma companies access to an experienced research network with world-class key opinion leaders and scientific thought leadership across all therapeutic areas. This makes it an ideal location for conducting clinical trials.

Australia is home to over 270 different ethnic groups. This means your trial results can be applied to almost any nationality on the globe. Furthermore, the Australian Institute of Health and Welfare maintains a repository of health data, which is a useful fount of information for sponsors.

The Australian Government offers grants and tax incentives that are available to clinical trial sponsors. Each year, the National Health Medical Research Council Fund provides substantial funding support (~AUD100 million) through various programs. In addition, the R&D Tax Incentive from the Australian Government can provide up to 43.5% for eligible R&D activities. These incentives can help reduce your tax bill and improve your cash flow, making it easier and more financially attractive to conduct clinical trials in Australia.

Australia has a long history of being politically and economically stable, which removes the risk of your trial being suspended due to political unrest or financial volatility.

The strong IP framework used in Australia allows a sponsor to market an invention with an appropriate exclusivity period (5 years). This allows the sponsor to recover their substantial investment costs.

The Australian Clinical Notification (CTN) scheme allows a streamlined approach for submission of essential clinical trial documents for approval by a Human Research Ethics Committee. They then notify the Australian Therapeutic Goods Administration that the proposed trial has been approved and will be conducted according to the National Health and Research Medical Council guidelines for the ethical conduct of trials in humans. This time saving not only benefits the trial sponsor in terms of cost-saving, but also expedites the time for the investigational drug/device to become available to the general population who will ultimately benefit from its use.

An additional benefit is that Australia abides by ICH, ISO, and GCP standards, which means your trial results will be acceptable to global agencies such as the United States Food and Drug Administration and the European Medicines Agency.

Austrade (the Australian Government Trade Commission) provides a Clinical Trials Industry Capability Report that provides you with all you need to know about companies and organisations that may be of assistance to your company and your trial.

Contact GLC to learn how we can help you determine which is the best pathway to take your product to Australia. If your product is viable for CTN or CTA and what you need to know beforehand.

We will create a report covering all the essential information specific to your product on the recommended pathways you can take. Along with important considerations that you should be aware of, regardless of the CRO you work with.

If you would like more information on how we can help, fill out the contact form below.