Singapore legislation
Regulation 12
of Medicines (Medicinal Products as Clinical Research Materials) Regulations 2016
Regulation 12
Notifications of unexpected serious adverse drug reactions
Subregulation 1
Where, during any clinical research that is not a regulated clinical trial, any USADR occurs in a subject that results in death or is life‑threatening, then the sponsor must ensure that —
all relevant information about the USADR is —
recorded; and
reported to the Authority as soon as possible and in any event not later than 7 days after the sponsor first becomes aware of the event; and
any additional relevant information about the USADR is —
recorded; and
sent to the Authority within 8 days of the record referred to in sub‑paragraph (i).
Subregulation 2
Where, during any clinical research that is not a regulated clinical trial, any USADR that is not referred to in paragraph (1) occurs in a subject, the sponsor must ensure that all relevant information about the reaction is —
recorded; and
reported to the Authority as soon as possible and in any event not later than 15 days after the sponsor first becomes aware of the event.
Subregulation 3
In this regulation —
Definition
“investigator’s brochure” means a document of an investigator of any clinical research that is not a regulated clinical trial, containing a summary of the clinical and non‑clinical data relating to the clinical research material relevant to the study of the material in subjects;
Definition
“serious adverse drug reaction” has the same meaning as in regulation 2(1) of the Medicines (Clinical Trials) Regulations 2016 (G.N. No. S 335/2016);
Definition
“USADR” means an unexpected serious adverse drug reaction in a subject following the administration of any clinical research material to the subject, the nature and severity of which is not consistent with the information about the material set out —
in the case of clinical research material in respect of which a product licence has been issued, in the product information leaflet or the investigator’s brochure relating to the material; and
in the case of any other clinical research material, in the investigator’s brochure relating to the material.