Singapore legislation

Regulation 30

of Health Products (Clinical Trials) Regulations 2016

Regulation 30

Pending clinical trials

Amended byS 431/2023 wef 31/12/2021

Subregulation 1

Amended byS 431/2023 wef 31/12/2021

This regulation applies to a clinical trial —

(a)

for which a certificate has been issued under the Medicines (Clinical Trials) Regulations (Rg 3) revoked by the Medicines (Clinical Trials) Regulations 2016 by (G.N. No. S 335/2016);

(b)

that is a trial of a medicinal product which is a therapeutic product as of 1 November 2016; and

(c)

that is on that date neither concluded nor terminated.

Subregulation 2

These Regulations apply to a clinical trial referred to in paragraph (1) in relation to that therapeutic product —

(a)

as if the trial is one for which the Authority has given authorisation under regulation 8 until the conclusion of the trial, and as if the conditions of any certificate issued for the trial are conditions of the authorisation;

(b)

where there is more than one sponsor for the trial, as if the lead sponsor declared for the issue of a certificate for the trial is the lead sponsor for the trial under these Regulations; and

(c)

where the consent for a person to be a subject in the trial has been obtained, or need not be obtained, in accordance with the revoked Medicines (Clinical Trials) Regulations, as if the consent is validly obtained, or need not be obtained, under these Regulations, until such time as the consent of another person, or the consent of a person, as the case may be, is required under these Regulations.