Singapore legislation
Regulation 25
Regulation 25
Notifications of unexpected serious adverse drug reactions
Subregulation 1
Where any USADR occurs in a subject during a clinical trial which results in death or is life‑threatening, 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 making the record referred to in sub‑paragraph (i).
Subregulation 2
Where any USADR occurs in a subject during the clinical trial, other than a USADR referred to in paragraph (1), 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
Upon a request made by the Authority, the sponsor must furnish to the Authority a report of —
the sponsor’s assessment of the risks associated with a USADR; and
the steps proposed to be taken —
to mitigate the risk; and
to inform the person whose consent is required for a person to be a subject or to continue to be a subject in the clinical trial, of the risk.
Subregulation 4
The sponsor must furnish the report referred to in paragraph (3) as soon as possible and in any event no later than 14 days after the Authority’s request.