Advantages
Australia is an attractive destination to undertake health and medical research.
There are many benefits to conducting clinical trials in Australia. We have:
- world-leading researchers and health professionals
- research infrastructure that supports multicentre studies
- a world class health and medical system
- a stable socio-political environment
- high standards that support integrity of trial operations
- a robust intellectual property system
- streamlined ethics and governance process
- investment and cost incentives.
High-quality research and facilities
Australia has a strong reputation for excellence in scientific and medical research, supported by world-class hospitals, research institutions and universities. Australia is internationally recognised for its highly trained clinical and scientific workforce and the high-quality data produced by skilled and experienced research teams.
Our high-quality clinical research facilities have state-of-the-art equipment for testing, treatment and analysis.
A world-class ranking for the quality of clinical research provides confidence in the findings of clinical trials conducted in Australia.
Standards of conduct
Clinical trials in Australia follow accepted international good clinical practice (GCP) standards of conduct, such as those developed by the:
- International Conference on Harmonisation (ICH)
- International Organization for Standardization (ISO).
Under the Therapeutic Goods Act 1989 and associated regulations, these GCP standards are mandatory for all Australian clinical trials involving unapproved medicines or medical devices. Many Australian researchers have international experience and are accustomed with GCP and other guidelines.
Because we adhere to the highest level of GCP standards, Australian clinical trial data and results are accepted by international regulatory agencies, such as the:
- US Food and Drug Administration
- European Medicines Agency.
The Therapeutic Goods Administration (TGA) has adopted the European Guideline CPMP/ICH/135/95 (and therefore the ICH E6 guidance) in principle. The TGA has modified some elements to be in line with local regulatory requirements.
Australian clinical trials adhere to:
- Australian clinical trial handbook
- Australian Code for the Responsible Conduct of Research
- National Clinical Trials Governance Framework which embeds clinical trial services into the routine provision of health services. It strengthens governance for clinical trials, provides clarity to those who deliver them, and helps to drive national consistency
- The National Standard Operating Procedures for Clinical Trials in Australia (National SOPs), outlining the minimum standards that need to be followed when conducting clinical trials.
Regulation, Systems and Processes
Australia has a fast and pragmatic regulatory pathway for clinical trials.
The TGA administer 2 schemes for the importation into or supply in Australia of unapproved therapeutic goods for use in a clinical trial, the:
- Clinical Trial Notification (CTN) scheme
- Clinical Trial Approval (CTA) scheme.
Clinical trials that do not involve the use of ‘unapproved’ therapeutic goods are not subject to the requirements of the CTN and CTA schemes.
More information about the schemes is available on the TGA's website.
Diverse and accessible participants
Australia is a multicultural country with:
- a diverse population that can meet recruitment needs
- an informed and willing population of potential trial participants
- a higher level of research participation than you would expect from a population of our size.
Australian clinical practices and some aspects of its healthcare system are similar to other OECD nations. Our diverse population means researchers can recruit a similar patient population to those countries.
Australia has inclusive recruitment practices and decentralised trial models, including telehealth options. This promotes active engagement with First Nations and geographically dispersed communities.
The Australian Institute of Health and Welfare collects:
- statistics on Australian risk factors, diseases and death in Australia
- links to online data collections, which can provide useful information for sponsors considering placing trials in Australia.
Investment and cost incentives
The Australian Government’s Research and Development (R&D) Tax Incentive encourages more industry investment in research and development. The incentive provides businesses investing in eligible research and development with tax offsets.
Australia offers competitive grant opportunities for health and medical research projects through the Medical Research Future Fund (MRFF) and National Health and Medical Research Council (NHMRC).
Seasonal differences
Seasonal differences between the northern and southern hemispheres allow trials dependent on seasonal factors to be conducted or continued in Australia, extending periods for patient recruitment. Examples include clinical trials for flu vaccines, allergy or respiratory diseases.
Strategic location
Positioned in the Asia-Pacific, Australia is an ideal hub for trials in the region and offers proximity to key markets. It is recognised as a global leader for early phase, industry-led trials.
Reforms to the operating environment
National reforms for a nationally harmonised and predictable research ecosystem that promotes Australia as a preferred destination for health and medical research are currently being undertaken. A key initiative is the National One Stop Shop (NOSS).
NOSS will simplify the current multi-jurisdictional approvals, reduce duplication and make it easier for patients, researchers and sponsors to find, conduct and participate in clinical trials and research.
More information
- MTP Connect – Australia's growth centre for the medical technologies, biotechnologies and pharmaceuticals sectors.
- AusBiotech – dedicated to promoting Australia as a key destination to conduct clinical trials.