FAQs: The Early Phase Australian Advantage for Biotech Companies

1. Why is Australia considered a strategic location for early-phase clinical trials? 

Australia offers a rare combination of regulatory efficiency, cost savings, high-quality clinical infrastructure, and global data acceptance, making it an ideal location for First-in-Human and early-stage trials.

2. How does the Clinical Trial Notification (CTN) scheme accelerate study start-up? 

Under the CTN scheme, clinical trials do not require direct review by the TGA. Once ethics approval is secured, trials can begin in just weeks—compared to months in many other regions—greatly accelerating development timelines.

3. What is the R&D Tax Incentive, and how does it benefit biotech companies? 

Eligible companies can receive a refundable tax offset of up to 43.5% on qualified R&D expenses. This can significantly reduce the net cost of clinical trials and improve capital efficiency, especially for early-stage biotechs.

4. Is data from Australian clinical trials accepted by global regulators?

Yes. Data generated in Australia is recognized by major regulatory agencies, including the FDA (U.S.), EMA (EU), MHRA (UK), and Health Canada, enabling global submission pathways.

5. How strong is Australia’s clinical research infrastructure and talent pool? 

Australia has a globally respected clinical research ecosystem, including world-class hospitals, experienced investigators, and high-performing trial sites with access to diverse patient populations.

6. What are the advantages of patient recruitment and retention in Australia? 

Australia offers faster recruitment due to population concentration in urban centers, national health data access, and high patient engagement. Retention rates are strong, contributing to cleaner datasets and lower dropout rates.

7. Can biotech companies use Australia as a base for broader Asia-Pacific expansion?

Yes. Australia is not only geographically strategic, but also serves as a gateway to Asia-Pacific markets, enabling efficient coordination and multi-country study execution in South Korea, Japan, China, and beyond.

8. How does Australia support intellectual property and long-term investment?

Australia provides robust IP protection, legal and political stability, and government support through biotech grants and innovation programs—creating a low-risk environment for clinical development.

9. What therapeutic areas are most commonly studied in Australia? 

Australia supports a wide range of trials, including oncology, rare diseases, gene and RNA-based therapies, neurology, infectious diseases, and cell therapy—with a growing track record in complex and innovative programs.

10. Why do biotech companies choose Novotech to run trials in Australia? 

Novotech is a globally recognized, full-service CRO headquartered in Sydney with deep regulatory expertise and a strong regional footprint. Named Australia’s Best CRO and Global CRO of the Year, Novotech offers end-to-end support to help biotech sponsors fully leverage the Australian Advantage with speed, quality, and scientific rigor.