Biotechnology sector guide for the R&D Tax Incentive

R&DTI determinations are binding advice about how the Department of Industry, Science and Resources (the department) interprets and applies the law when administering the R&DTI. The Industry Research and Development (Clinical Trials) Determination 2022 applies to activities involved in clinical trials that meet the R&DTI’s requirements for core R&D activities.

If you are conducting clinical trials for an unapproved therapeutic good in Australia, this determination could simplify your application for the R&DTI. You may only need to show that your activities are covered by the determination rather than explaining how they meet all the core R&D activity requirements.

The department provides guidance which covers how this determination can be used when applying for the R&DTI and when applying for an advance or overseas finding.

Exclusions and R&D not covered by the determination

Not all clinical trial activities are covered by the clinical trials determination. However, these activities may still be eligible under the R&DTI. You will need to self-assess whether these activities meet the eligibility requirements of the program before applying.

Additionally, you can only rely on the clinical trials determination if your activity meets the requirements in section 5.