Australia is recognised as one of the best places in the world to conduct clinical trials

Australia is home to the world's top scientists, doctors and healthcare professionals. It boasts a world-class medical research and healthcare infrastructure (Lab), a stable socio-economic environment, a multi-ethnic population and a robust intellectual property system. Its efficient regulatory system, including a fast clinical trial approval system, robust support services and globally competitive R&D investment tax incentives, has helped Australia become one of the leading destinations for clinical trials.

Every year, companies in the pharmaceutical, biotech and medical device sectors launch around 1,000 new clinical trials in Australia, with an investment of $1 billion. The top 10 global pharmaceutical companies alone invest around $200 million a year in clinical trials in Australia.

Companies around the world benefit from simplified processes and rapid translation of clinical trial reports, ensuring that the results are authentic and immediately available to other management departments.

To further reduce research start-up times, facilitate patient recruitment, and develop standard cost lists for clinical trials, the Australian government, in collaboration with industry and other stakeholders, is undertaking a series of reforms. These reforms will make Australia more attractive as a location for clinical trials, while maintaining the highest quality and ethical standards.

【Australia also has the following advantages】：

1、First-class medical research infrastructure and a well-trained workforce
2、World-class health care system
3、Attractive tax incentives for research and development of clinical trials
4、A fast and pragmatic approach to regulation
5、Clinical data follow the strictest international standards
6、A sound intellectual property protection system
7、The state attaches importance to achieving continuous improvement through government reform and policy innovation
8、Ethnically diverse, native English speakers
9、Close to Asia


Choose the advantages of Australian clinical trials：

1、Minimize the regulatory burden

For more than two decades, Australia's clinical trial notification System (CTN) has been the global standard of best practice in minimising the regulatory burden on clinical trial sponsors.

Most commercially sponsored clinical trials in Australia are conducted using the clinical trial notification model. All data related to the proposed clinical trial (including the trial protocol) will be submitted directly by the investigator to the Ethics Committee of the institution at the request of the relevant sponsor. Ethics committees individually assess the scientific validity of trial designs, the safety and efficacy of drugs or devices, the ethical acceptability of trial procedures, and the approval of trial protocols.

The organization conducting the clinical trial will conduct a final review of the trial conducted in its own organization on site. Under the clinical trial notification scheme, only the Australian Drug Administration (TGA), the Australian agency similar to the US Food and Drug Administration (USFDA), is informed that any data related to the trial will not be reviewed after it has received approval from the trial unit. The TGA has no authority to inspect and investigate the administration of clinical trials.

The clinical trial notification program avoids unnecessary duplication of effort and saves significant time and money for sponsors conducting clinical trials in Australia; This time and money can be allocated to other research projects or other activities.

2、Offer attractive tax incentives

Under the Australian government's Research and Development (R&D) tax credit, companies with total annual business of less than A $20 million are entitled to a 45% tax credit, while companies with total business of more than A $20 million are entitled to a 40% non-refundable tax credit on qualified R&D expenditure. Research and development tax incentives are designed to make it easier for companies to anticipate the tax benefits and enjoy them more effectively.

Unlike similar schemes in other countries, the policy does not require companies in Australia to demonstrate year-over-year increases in research and development spending in order to claim tax benefits. There is also no requirement that intellectual property derived from eligible R&D projects be retained in Australia. It values the intrinsic value of the R&D process itself, regardless of the final "location" of its final intellectual property.

Most importantly, the R&D Tax incentive provides a globally competitive incentive for both domestic and international companies to conduct R&D activities in Australia. In fact, according to a recent report by multinational accounting firm KPMG, Australia is one of the top 10 most competitive destinations for R&D investment.

3、Protect valuable intellectual property

Australia has one of the most robust and stable intellectual property systems in the world.

Some of the key advantages of Australia's IP system include：

3.1 The definition of patentable subjects is broad
In Australia, patents apply to a variety of therapeutic inventions, including new active ingredients, new formulations, extracts of (therapeutic) natural products, and new therapeutic methods.

3.2 Extension of patent term
Under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Australia grants (standard) patent owners a 20-year period of protection. However, since 1999, Australia has also granted patent owners involving pharmaceutical materials the right to apply for the restoration of the patent period, which is called a "term extension". This right allows the patent owner to extend the patent period by up to five years in order to cover the time taken in the registration approval process, resulting in an effective patent period of up to 15 years from the date on which the new pharmaceutical material was first listed in the Australian Register of Therapeutic Goods.

3.3 Data exclusivity
In addition to patent protection, Australia also provides data exclusivity for new pharmaceutical products for five years. Australia's data exclusivity laws prohibit competitors from using proprietary safety and efficacy data for a period of five years, starting from the date a new drug or vaccine is first listed in the Australian Register of Therapeutic Goods.

3.4 Innovation patent
In Australia, innovation patents last up to eight years, compared to the 20-year term of a standard patent, and are designed to protect inventions that do not yet meet the threshold of invention required by a standard patent. Innovation patents are a relatively quick and inexpensive means of obtaining intellectual property protection for new medical devices or dispensing materials, methods, or processes.


Wiselink AU advantage

1、Wiselink AUIt is a national technology and medical industry venture capital institution。
2、Technical research and development cooperation, clinical trial department results transformed medicine consulting professional training and investment and financing services.
3、We have maintained long-term close contact with Australia's famous research and development institutions, clinical trial centers, pharmaceutical enterprise investment and financing institutions and relevant government departments.
4、The docking and integration of resources, the global layout to establish transnational technology as a channel.