Singapore legislation
Regulation 8
Regulation 8
Application for authorisation for clinical trial
Subregulation 1
The sponsor must obtain authorisation by the Authority for the clinical trial under regulation 7(2)(a)(i) before the commencement of the trial.
Subregulation 2
The application for authorisation must be made in the form and manner specified on the Authority’s website.
Subregulation 3
Where the application is for an authorisation of a clinical trial in an emergency situation, the Authority must not authorise the trial unless a principal investigator, who is a qualified practitioner and who is conducting the trial, and 2 specialists who are not conducting the trial certify in writing that —
the trial needs to be conducted on potential subjects who are facing a life‑threatening situation to determine the safety or efficacy of a therapeutic product or applicable CTGT product;
available treatments or procedures are unproven or unsatisfactory;
there is a reasonable prospect that participation in the trial will directly benefit the potential subjects because —
the potential subjects are facing a life‑threatening situation that necessitates intervention;
the appropriate non‑clinical and clinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the proposed use of the therapeutic product or applicable CTGT product to provide a direct benefit to the potential subjects; and
the risks associated with the trial are reasonable in relation to what is known about —
the medical condition of the potential subjects;
the risks and benefits of standard therapy, if any; and
the risks and benefits of the proposed use of the therapeutic product or applicable CTGT product;
the potential subjects are unable to consent to being subjects as a result of their medical condition;
it is not feasible to obtain consent from the legal representatives of the potential subjects within the window period;
there is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the trial; and
the trial cannot practicably be carried out if the consents referred to in regulation 16 must be obtained.
Subregulation 4
The Authority may authorise a clinical trial subject to such conditions as the Authority thinks necessary and may, from time to time, by notice in writing to the sponsor —
modify or remove any condition of the authorisation; or
attach any new condition to the authorisation.
Subregulation 5
The conditions mentioned in paragraph (4) may include a condition requiring the sponsor to obtain and maintain insurance to provide compensation in the event of injury or loss arising from the clinical trial on such terms as the Authority may approve.
Subregulation 6
The Authority may refuse to authorise, or suspend or revoke any authorisation of, a clinical trial.
Subregulation 7
Any person aggrieved by a refusal, suspension or revocation referred to in paragraph (6) may appeal to the Minister, whose decision is final.