business.gov.au

Authority to Conduct Clinical Trials - Australian Government

Description

You will need 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 Notification (CTN) Scheme and the Clinical Trial Approval (CTA) 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 Approval (CTA) Scheme).

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.

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 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health and Aged Care

Therapeutic Goods Administration

Contact details

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