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.