Australia is an attractive place to undertake trials and research. The clinical trial industry represents a significant opportunity for Australia.
There are many benefits to running your clinical trial in Australia. We have:
- some of the world's best researchers and health professionals
- a world-class research infrastructure
- a stable socio-political environment
- high standards that ensure confidence in the scientific conclusions reached by clinical trials conducted in Australia
- a robust intellectual property system
- a simple and efficient regulatory regime.
High-quality research and facilities
Australia has a strong reputation for the quality of its scientific and medical research. Australia is internationally recognised for its highly trained clinical workforce and the high-quality data produced by its experienced, trained (and accredited) research teams.
Our high-quality clinical research facilities have state-of-the-art equipment for testing, treatment and analysis.
This means we can have 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 familiar 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 Australian 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.
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.
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 the United States, Canada and most European countries. Our diverse population means researchers can recruit a similar patient population to those countries.
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.
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.
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.
- Australia: a go-to destination for clinical trials – read the Australian Government Trade Commission’s analysis of our clinical trials industry
- MTP Connect – Australia's growth centre for the medical technologies, biotechnologies and pharmaceuticals sectors.