R&D Tax Incentive - Australian Investment Council

 

The Industry Research and Development (clinical trials, phase 0, I, II, III, pre-market pilot stage, pre-market pivotal stage, for an unapproved therapeutic good) Determination 2022 was registered on the Federal Register of Legislation on Thursday 31 March 2022. The Instrument will commence on Friday 1 April 2022.

The determination facilitates certain clinical trials R&D registration and Advance and Overseas Findings applications by allowing companies to reduce the time it takes you to complete an application by using existing regulatory frameworks. View the determination on the Federal Register of Legislation.

Determinations provide stakeholders with greater certainty, and reduce their compliance and administrative burden when registering activities that fall under the determination.

AusIndustry consulted with the Australian Taxation Office (ATO) and Department of Health, and engaged in a public consultation process.

The RDTI is the most critical policy available to life sciences companies and the Determination is a welcome and positive first step in cementing certainty to a program that has been incentivising investment into the sector for over 10 years. Clinical trials work in a highly-regulated environment and industry has become familiar with eligibility over the past 10 years; this Determination offers eligibility certainty and consistency and acts as a formal indicator to the national and international life sciences ecosystem that clinical trials are a recognised and eligible core activity under the RDTI


AusBiotech

Determinations are designed to:

  • strengthen Australia’s reputation for competitive research and development incentives
  • integrate processes across government departments and facilitate access to government services
  • help attract more investment to and create jobs in Australia.

More information

Check out the Clinical trials determination guide.

Assess if your R&D activities are eligible for the R&D Tax Incentive.

Find out out how to apply for the R&D Tax Incentive.