Authority to Conduct Clinical Trials - Australian Government

Description

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
  • 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

Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application All

Fees are listed on the attached document.

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Regulations 1990 AG

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Clinical Trials, Medicines Regulation Division

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Phone: 1800 020 653
Phone: 02 6232 8106
Fax: 02 6232 8112
Email: clinical.trials@tga.gov.au