Singapore legislation

Regulation 22

of Health Products (Clinical Trials) Regulations 2016

Regulation 22

Suspension or termination of clinical trial

Subregulation 1

The Authority may require the suspension or termination of a clinical trial, or any part of a clinical trial, authorised by or notified to it, or the suspension or termination of the conduct of such a trial at a particular trial site, if, or if the Authority has reasonable grounds to suspect that —

(a)

any information provided in respect of the application for authorisation or the notification of the trial is false or misleading;

(b)

any sponsor, principal investigator or person assisting the principal investigator has contravened, is contravening or is likely to contravene —

(i)

any condition to which the authorisation or acceptance of notification of the trial is subject; or

(ii)

any provision of these Regulations;

(c)

any ground for the conduct of the trial on the basis of scientific validity is no longer applicable or true; or

(d)

the continuance of the trial will compromise the safety of any subject of the trial.

Subregulation 2

Where the Authority has suspended or terminated a clinical trial, the sponsor and a principal investigator must ensure that the suspension or termination is adhered to by all persons involved in the trial.

Read in full context — Health Products (Clinical Trials) Regulations 2016 →