Singapore legislation
Regulation 7
Regulation 7
Requirement for authorisation for or notification of clinical trial
Subregulation 1
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.
Subregulation 2
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.