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.
A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.
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.
To be determined during the application process.
Fees are listed on the attached document.
Department of Health
Therapeutic Goods Administration
Therapeutic Goods Act 1989 (Australian Government)
Therapeutic Goods Regulations 1990 (Australian Government)
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