Clinical Trials in Australia & New Zealand (ANZ)

The regulatory environment in Australia & New Zealand offers a significant strategic opportunity to international biotech companies who can take advantage of a uniquely fast and pragmatic regulatory pathway for early phase clinical trials.

The simplicity and efficiency of Local Regulatory and Ethics (IRB) processes often means our clients can defer regulatory submissions by initiating their clinical programs in Australia and/or New Zealand and commencing subject treatment within a single review cycle of 6-8 weeks from submission. The outcome for our clients is earlier human data, more engaged discussions with international regulators and investors and a better use of investors capital throughout.

As confirmed by numerous international accountancies, you may be eligible for the Australian Research & Development (R&D) Tax Incentive Program - the most attractive currently available internationally. To receive a 43.5% refundable tax offset for R&D spend in Australia, eligibility criteria includes:

  • R&D activities must be through Australian resident company or Australian permanent establishment
  • Under AUD $20M annual aggregate turnover
  • Receive 38.5% tax credit for eligible companies if annual aggregate turnover is in excess of AUD $20M

In summary, the ANZ Timeline Advantage:
  • Defer costly IND submission - if you’re ready to submit an IND/CTA then you are likely ready to commence trials in Australia or New Zealand
  • Obtain POC/FIH data earlier in your development timeline
  • Achieve earlier ‘next round’ funding supported by POC/FIH data
  • Submit more complete IND/CTA applications
  • Make a faster go/no-go decisions
  • Phase 1 studies – ‘GMP-like’ is acceptable

To speak to an expert about the R&D Tax Incentive Program or for further information on our regional advantages or regulatory environment, contact us.