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Regulatory Process

Accelerated clinical development path supported by a central ethics process

Due to the regulatory framework and approval process in Australia, studies can be approved within 4-5 weeks of Institutional Review Boards (IRBs) submission, including Human Research Ethics Committees (HRECs) review. This gives our clients a strong advantage over those still choosing to conduct Phase I Studies in the U.S.

You don’t need an IND application to undertake a Clinical Trial in Australia

Because sponsors aren’t required to submit an Investigative New Drug (IND) application in Australia, First-in-Patient studies can be conducted within 6-8 weeks. This means speed-to-market, flexibility and lower costs—without compromising on quality or ethics.

Australian data outputs meet global FDA and EMA standards

Our research data can be used to support international regulatory applications, including U.S. Investigational New Drug Food and Drug Administration (IND FDA) and European Medical Agency (EMA) submissions, making the study process highly efficient and cost-effective.

How Australia’s Clinical Trial regulatory process works

Clinical Trial Notification scheme

Australia uses a Clinical Trial Notification (CTN) scheme to regulate our clinical trials.

Our regulators delegate the trial review process to Human Research Ethics Committees (HRECs), and sends a notification of approval to the Australian Therapeutic Goods Association (TGA).

The TGA is Australia’s government regulator of medicines and medical devices, equivalent to the FDA in the U.S. or EMA within Europe.

The process of the scheme reduces the regulatory burden on clinical trial sponsors, enabling them to maximize critical resources: time and money.

Understanding the Clinical Trial Notification scheme process 

  1. The sponsor notifies the Therapeutic Goods Association (TGA) they want to sponsor a clinical trial, using the online Clinical Trial Notification form.
  2. Human Research Ethics Committee (HREC) reviews the:
    1. scientific validity of the trial design
    2. balance of risk versus harm of the therapeutic good
    3. ethical acceptability of the trial process
  3. Once the trial is approved by HREC, we are notified and make the final decision whether to conduct the trial
  4. First-in-Patient (FPI) happens within 6-8 weeks of our approval
  5. Once the trial begins, HREC monitors how the trial is being conducted.

Australia’s TGA legislation

Australia’s TGA legislation ensures the use of therapeutic goods in a clinical trial must be in accordance with:

Learn more about conducting Clinical Trials with Nucleus Network

 

Online resources for conducting Clinical Trials in Australia

The Australian Clinical Trial Handbook 

Australian Government Department of Health and Aging Therapeutic Goods Association
A practical guide to the conduct of Clinical Trials in the Australian context

Why conduct a clinical trial in Australia?

Australian Government National Health and Medical Research Council 
Overview of Australia’s advantages as a place to conduct clinical trials

Clinical Trial Notification (CTN) scheme 

Australian Government Department of Health and Aging Therapeutic Goods Association
Explanation of the Clinical Trials Notification Scheme in Australia

Melbourne: A World Leading Biotech Hub

Victorian State Government
Melbourne is a vibrant, commercial biotech sector with R&D infrastructure and advanced manufacturing expertise

 

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