Australia is widely recognised as a leading location for multi-regional clinical trials (MRCTs) in Asia Pacific due to its excellent health system and streamlined regulatory framework that facilitates rapid start-up of clinical trials, especially in early-stage development.1 Currently, it ranks as the 7th most preferred location worldwide for registered MRCTs, according to the Korea Clinical Trials Statistic Handbook (2022, KoNECT).
If private, rather than public, research sites are involved, then the start-up time can be further reduced to a best case of 8 weeks. Fast study initiation, however, is not the only factor positioning Australia as a leading destination for MRCTs.
Clinical trials contribute approximately $1.4 billion to the Australian economy annually, including $650 million in foreign investment. Australia’s reputation in clinical research is bolstered by high-quality infrastructure, an ethnically diverse population, stringent yet efficient regulatory systems, and globally recognised clinicians. Over 8,000 Australians are employed in health and medical research, and more than 60% of research outputs are ranked as “above” or “well above world standard”.3
In addition, Australia offers clinical trials across various biologics sub-sectors, including gene therapies, cell therapies, antibody-based treatments, CAR-T therapies, RNA-based therapies and radiopharmaceuticals.1
Australia is internationally renowned for its highly trained clinical workforce and the exceptional quality of data produced by its research teams. The country’s state-of-the-art clinical research facilities are equipped with cutting-edge technology for testing, treatment, and analysis. Australia's medical research is ranked 7th globally, with over 1,200 biotech companies, 55 medical research institutes, and 40 medical research-focused universities.5
The Australian government has implemented several initiatives to enhance the clinical trial environment and attract foreign investment. Key initiatives include:
Announced in May 2024, this package represents a “once in a generation” transformation of health and medical research, with a total investment of $1.89 billion. This includes $1.4 billion in new research via the Medical Research Future Fund (MRFF) and $411 million to support researchers tackling Australia’s biggest health challenges.
This initiative, boosted by government funding of 18.8 million, will streamline clinical trial processes by harmonising regulations across Australia. The platform will make it easier for patients, researchers, and industry stakeholders to find, conduct, and participate in clinical trials.
A $750 million initiative over a decade (2024-2034) to support clinical trial activity, particularly in rare diseases, rare cancers, and unmet needs. It also aims to attract investigator-led international trials to Australia.
The RDTI helps companies offset the costs of eligible research and development, offering both refundable and non-refundable tax offsets depending on the company’s turnover and R&D expenditure.
Providing $5 million to organisations to support clinical trials of mRNA-based vaccines and therapeutics.
This fund offers venture capital to help biomedical discoveries transition into tangible products, services, and outcomes, ensuring Australia remains competitive in the global health research landscape.
Australia’s regulatory body, the Therapeutic Goods Administration (TGA), oversees clinical trials involving 'unapproved' therapeutic goods. The two primary pathways for approval are the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme.
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CTN Scheme |
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CTA Scheme |
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Clinical trials in Australia must have a local sponsor with a registered legal entity in Australia. An overseas company, person or entity, cannot be the 'local sponsor' of the trial in Australia. The local sponsor must submit the CTN or CTA. The trial sponsor is responsible for the initiation, management and financing of the trial and the associated medico-legal responsibility.1 The Guideline for Good Clinical Practice and ISO 14155 allows a trial sponsor (client) to delegate any or all of the sponsor's trial-related duties and functions, including safety reporting, to a third party such as a CRO. Clinical trials undertaken in Australia do not require US FDA Investigational New Drug (IND) application approval.
Research governance involves site-specific assessments (SSA) and authorisations necessary for clinical trial commencement. Public sites typically take longer to complete research governance approval (3-6+ weeks), while private sites can approve trials in as little as 1-2 weeks.
With its fast regulatory approvals, government-backed incentives, and world-class infrastructure, Australia is an attractive research destination. As the global demand for novel therapies grows, Australia is well positioned to lead the next wave of clinical advancements, from mRNA and gene therapies to personalised medicine and beyond.
Precision for Medicine, which registered in Australia in 2019, draws on extensive experience through the acquisition of Egan Lee CRO, a company with over 20 years in clinical monitoring and site management. Precision's Australian team offers expertise in clinical operations, project management, regulatory, and medical monitoring across the APAC region.
Assess how Australia may fit within your clinical program.