In Part 1 of this series, we set out the regulatory pathways available to sponsors looking to conduct clinical trials in Australia, principally the Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) schemes administered by the Therapeutic Goods Administration (TGA).
In Part 2, we turn to the stakeholders. Australia's clinical trial framework involves a range of bodies whose roles, and the sequence in which they play their role, are not always obvious to first time Australia sponsors. Below, we follow the order in which a sponsor is likely to encounter each stakeholder, from pre-entry considerations through to day-to-day trial operations.
Before you arrive
Before filing any applications, foreign sponsors should engage with stakeholders involved in trial structure and funding.
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Stakeholder
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Role
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Key Considerations for Foreign Sponsors
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Administers the R&D Tax Incentive (R&DTI), which provides a tax offset for eligible clinical trial expenditure incurred in Australia. |
The R&DTI is often a key reason for many foreign sponsors to decide to run a trial in Australia. Eligible entities with aggregated turnover below $50 million can access a refundable tax offset equal to their company tax rate plus a 23% premium (typically 43.5% for companies paying the 48% corporate tax rate). A greater number of larger companies may become eligible or increase their ability to receive a non-refundable tiered offset. Foreign sponsors typically conduct trials through an Australian subsidiary or registered entity to access the incentive. AusIndustry co-administers program registration, while the ATO assesses the tax component. Structuring decisions made early, including which entity contracts with sites and CROs, directly affect eligibility. |
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Administers Australia's foreign investment review framework. FIRB is the advisory panel; Treasury holds decision-making authority. |
FIRB review is important for foreign sponsors to consider when they are acquiring an interest in an Australian research entity, or where the arrangement involves assets (including data or intellectual property) that may trigger notification obligations. Heightened scrutiny applies to foreign government-related entities regardless of deal size. Australia's critical infrastructure and sensitive national security business categories have expanded significantly since 2020, and health-related data increasingly falls within scope. Sponsors should assess FIRB at the structuring stage, not as an afterthought. |
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Regulates compliance with the Privacy Act 1988 (Cth) and the Australian Privacy Principles (APPs) listed in Schedule 1, including in relation to health information. |
Clinical trials involve the collection, use, and disclosure of sensitive health information at scale. The APPs apply to most sponsors operating through an Australian entity. Key issues include consent for collection and secondary use of data, cross-border disclosure to offshore sponsors or data repositories, and obligations under the Notifiable Data Breaches scheme. Sponsors should address any data transfer arrangements in trial agreements before a trial commences. |
Regulatory approval
As we described in Part 1, the TGA and Human Research Ethics Committees are the two bodies whose approvals every trial must obtain before it can commence at any site.
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Stakeholder
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Role
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Key Considerations for Foreign Sponsors
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The primary federal regulator of therapeutic goods, including investigational products used in clinical trials. |
The TGA administers the CTN and CTA pathways described in Part 1. Most commercial trials proceed via the CTN pathway. Foreign sponsors should also be aware of the TGA's adoption of Good Manufacturing Practice (GMP) requirements for investigational products manufactured overseas, and of serious breach and adverse event reporting obligations that apply throughout the trial. |
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Independent committees that review and approve the ethical acceptability of research involving human participants. |
Ethics approval is mandatory before a trial can commence at any site. Under the National Mutual Acceptance (NMA) scheme, a single HREC approval review is recognised across public health sites in most jurisdictions, avoiding the need for separate ethics applications at each site. HRECs apply the standards set out in the NHMRC's National Statement and the International Council for Harmonisation E6 Good Clinical Practice (ICH E6 GCP) guidelines. The choice of lead HREC and the timing of submission affects the overall approval timeline. |
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Australia's peak body for health and medical research standards, and publisher of the ethical framework that HRECs apply. |
Foreign sponsors will not typically engage directly with the NHMRC, but its National Statement on Ethical Conduct in Human Research is the foundational document applied by HRECs when reviewing trial protocols. Understanding the requirements (particularly on informed consent and participant welfare) is critical. The NHMRC is also a significant funder of investigator-initiated research, which is relevant to sponsors pursuing collaborative or co-funded trial models. |
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The Commonwealth regulator responsible for approving dealings with genetically modified organisms (GMOs) under the Gene Technology Act 2000 (Cth). |
Trials involving gene therapies, genetically modified cells (such as CAR-T therapies), and other GMO-based products require a licence or exemption from the OGTR. This approval is separate from, and in addition to, TGA and ethics approval. Sponsors must also engage the Institutional Biosafety Committee at each trial site. Given the growth in cell and gene therapy trials, sponsors in this space should factor OGTR timelines into their planning from the outset. |
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A publicly accessible register of clinical trials conducted in Australia and New Zealand, operated by the NHMRC Clinical Trials Centre at the University of Sydney. |
The NHMRC’s National Statement requires that clinical trials be registered on a publicly accessible register before recruitment of the first participant. Most trials conducted solely in Australia or New Zealand are registered on the ANZCTR. Multinational trials are typically registered on ClinicalTrials.gov. Registration is straightforward but must be completed before enrolment commences. |
Getting into the Sites
Once a sponsor obtains ethics approval, each trial site must grant its own authorisation before recruitment can begin. This is often where delay occurs, as requirements vary across jurisdictions and institutions. For multi-site trials, careful co-ordination is essential to keep timelines on track.
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Stakeholder
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Role
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Key Considerations for Foreign Sponsors
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State & Territory Health Departments |
Govern public health systems within each jurisdiction, including the public hospitals where most Australian trials are conducted. |
Each state and territory sets its own requirements for indemnity, insurance, and allocation of liability in clinical trial agreements. These requirements can be a source of friction for foreign sponsors accustomed to more uniform contracting environments across a multi-site trial. Where public health institutions are involved, early engagement is important. |
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Trial Sites |
The hospitals, clinics, or research institutions at which the trial is conducted. |
Trial sites have responsibility for the conduct of the trial within the institution. The Medicines Australia standard form agreements set out the site's obligations in detail, including record-keeping, adverse event reporting, and investigational product handling. Early submission of draft agreements, and early negotiation of any deviations from the Medicines Australia standard form, reduces risk associated with protracted negotiation. |
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Peak industry body for the innovative pharmaceutical industry in Australia, and publisher of standard form CTRAs and the industry Code of Conduct. |
Medicines Australia publishes standard form Clinical Trial Research Agreements (CTRAs), developed in collaboration with the National Clinical Trial Agreement (NaCTA) Panel (comprising representatives from all Australian states and territories) and the Medical Technology Association of Australia (MTAA). These templates have become the de facto industry standard for contracting between sponsors and trial sites. Sponsors who deviate materially from the standard form typically encounter longer negotiation timelines. The standard form CTRAs include indemnity provisions that allocate liability between the sponsor, the trial site, and the investigator. Separately, the Medicines Australia Code of Conduct governs member company interactions with healthcare professionals. This includes activities that arise in the context of trials, such as investigator meetings, advisory boards, and speaker arrangements. Compliance obligations under the Code, which is widely understood to represent industry best practice (even for non-members) should be factored into trial planning from the outset. |
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Research Governance Officers (RGOs) |
Officers within each institution responsible for managing the site-specific assessment (SSA) and granting site authorisation for research. |
After obtaining ethics approval, each trial site must complete an SSA to confirm it has the capacity, resources, and appropriate arrangements in place to conduct the trial. The RGO manages this process. Each state and territory uses different portal systems for governance applications (for example, REGIS in NSW, ACT and Tasmania, or ERM in Victoria and Queensland), which can be a source of confusion for foreign sponsors. Early engagement with RGOs, and familiarity with the relevant portal, reduces the risk of delays at site activation. |
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The national body responsible for health care safety and quality standards, and publisher of the National Clinical Trials Governance Framework. |
The National Clinical Trials Governance Framework describes the governance structures and processes that health service organisations are expected to have in place when conducting clinical trials. While sponsors do not engage directly with the Commission, the Framework informs the policies and procedures applied by trial sites and their RGOs. Understanding these expectations can help sponsors anticipate the documentation and assurances that sites will require. |
Looking Ahead
Australia remains one of the most attractive jurisdictions for the conduct of clinical trials, with a predictable and enabling regulatory environment, high-quality research infrastructure, and access to diverse patient populations. The Inter-Governmental Policy Reform Group is currently leading national reforms to further streamline the clinical trial ecosystem, including through the National One Stop Shop initiative, which aims to create a more consistent national system for ethics and governance applications. For sponsors, the key to a smooth market entry lies in understanding who to engage, and when — building relationships with the right stakeholders early can significantly reduce delays.
Part 3 of this series will examine the contracts that connect these stakeholders, including customary indemnity and insurance arrangements, intellectual property provisions, and implementing Australian privacy law in relation to health data.
