R&D Tax Incentive determinations are notifiable instruments that set out how the law is interpreted and applied when administering the R&D Tax Incentive program. When a determination is in force it is binding on Industry Innovation and Science Australia and its delegates except in certain circumstances, such as during a review of a reviewable decision. If an application or registration is examined, any applicable determinations will be applied.

View the determination on the Federal Register of Legislation.

Background to this determination

Clinical trials require careful planning, monitoring and regulatory oversight to minimise risks. Activities involved in clinical trials that are covered by this determination are deemed to meet the requirements of the R&D Tax Incentive for being ‘core R&D activities’. That is, the outcome of clinical trial activities covered by this determination cannot be known or determined in advance and can only be determined by applying a systematic progression of work, and that clinical trials covered by the determination are conducted for the purpose of generating new knowledge.

This determination was developed in consultation with the Australian Taxation Office, the Department of Health and through public consultation. It was approved by Industry Innovation and Science Australia and came into effect on 1 April 2022.

This clinical trials determination simplifies application to the R&D Tax Incentive program and provides certainty for companies whose activities fall within the scope of the determination.

Using the determination when you register

The determination can be used by companies conducting clinical trials when applying to register those activities under the R&D Tax Incentive program and describing ‘core R&D activities’.

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Using the determination when applying for an Advance or Overseas Finding (AOF)

Some organisations apply for advance or overseas findings to seek certainty about whether their activities are core R&D activities before they register.

Please note: For AOF applications, the determination can only be used if all parts of the core R&D activity are occurring solely in Australia. If any part of the activity occurs overseas; e.g., if the evaluation or conclusions are sent to a parent company overseas, then the activity will not be deemed to be an Australian core activity.

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Exclusions and R&D not covered by the determination

As some clinical trials do not involve an unknown outcome and/or they involve commercialisation activities, they are not covered by this determination.

Activities not covered by the determination may still be a core R&D activities. An R&D entity will need to demonstrate that those activities meet the criteria independently, without the support of this instrument.