7. Requirement for authorisation for or notification of clinical trial

The Authority must specify on the Authority’s website —

the clinical trials that require its authorisation; and

the clinical trials which, because the trials only involve the use of any therapeutic product or applicable CTGT product that is a registered health product and pose no, or minimal, additional risk to the safety of subjects compared to normal clinical practice, need only be notified to the Authority.

A person must not commence or conduct a clinical trial unless —

either —

if the trial is one that must be authorised by the Authority, it has been so authorised in accordance with regulation 8; or

if the trial need only be notified to the Authority, it has been so notified and confirmation of the Authority’s acceptance of the notification has been received, in accordance with regulation 9; and

the conduct of the trial has been approved by an institutional review board.

The Authority must specify on the Authority’s website —

the clinical trials that require its authorisation; and

the clinical trials which, because the trials only involve the use of any therapeutic product or applicable CTGT product that is a registered health product and pose no, or minimal, additional risk to the safety of subjects compared to normal clinical practice, need only be notified to the Authority.

A person must not commence or conduct a clinical trial unless —

either —

if the trial is one that must be authorised by the Authority, it has been so authorised in accordance with regulation 8; or

if the trial need only be notified to the Authority, it has been so notified and confirmation of the Authority’s acceptance of the notification has been received, in accordance with regulation 9; and

the conduct of the trial has been approved by an institutional review board.