Authority to Conduct Clinical Trials - Australian Government

Service summary

You will require this authority if you intend to conduct clinical trials of therapeutic goods or biologicals. There are two schemes under which clinical trials involving therapeutic goods may be conducted, the Clinical Trial Exemption (CTX) Scheme and the Clinical Trial Notification (CTN) Scheme.

These schemes are used for clinical trials involving:

  • Any product not entered on the Australian Register of Therapeutic Goods; or
  • Use of a registered or listed product in a clinical trial beyond the conditions of its marketing approval.

The first scheme involves notifying the Agency of the intention to conduct a clinical trial (Clinical Trial Notification (CTN) Scheme).

The second involves the evaluation of an application to conduct the trial (Clinical Trial Exemption (CTX) Scheme).

Please consult the Contact Officer for more information.

Service type

Licence

A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.

Eligibility requirements

Clinical trials must have an Australian sponsor. As the sponsor, you will be that person, body, organisation or institution who takes overall responsibility for the conduct of the trial and signs the relevant form. The sponsor usually initiates, organises and supports a clinical study and carries the medico-legal responsibility associated with the conduct of the trial. Please consult the Contact Officer for more information.

Duration

To be determined during the application process.

Fees

 TypeDescription
ApplyApplication

Fees are listed on the attached document.

Other resources

 Resources
Comply Summary of Fees and Charges Opens in a new browser window

Administering agency

Department of Health
Therapeutic Goods Administration

Act(s) name

Therapeutic Goods Act 1989 (Australian Government)

Regulation(s) name

Therapeutic Goods Regulations 1990 (Australian Government)

Contact details

Clinical Trials, Medicines Regulation Division
Department of Health
Therapeutic Goods Administration


Operating address:
136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address:
PO Box 100
Woden
Australian Capital Territory 2606

Phone:

1800020653

Phone:

02 62328106

Fax:

02 62328112
clinical.trials@tga.gov.au

Supporting information

Disclaimer

The information contained on the Australian Business Licence and Information Service (ABLIS) web site, or via packages or other sources is intended for general guidance only.

To the full extent permitted by law, the Federal, State, Territory and Local Governments make no representations or warranties (expressed or implied) in relation to the information, including its accuracy, currency or completeness.

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To the full extent permitted by law the Federal, State, Territory and Local Governments, their employees and agents do not accept any liability for any reason, including without limitation, liability in negligence, to any person for the general information which is provided herein, or in respect of anything, including the consequences of anything done, or not done, by any such person in whole or partial reliance upon the information.