Food and Drug Regulations

C.05.014 (1) During the course of a clinical trial, the sponsor shall inform the Minister of any serious unexpected adverse drug reaction in respect of the drug that has occurred inside or outside Canada as follows:

• (a) if it is neither fatal nor life threatening, within 15 days after becoming aware of the information; and

• (b) if it is fatal or life threatening, within seven days after becoming aware of the information.

(2) The sponsor shall, within eight days after having informed the Minister under paragraph (1)(b), submit to the Minister a complete report in respect of that information that includes an assessment of the importance and implication of any findings made.

(3) Sections C.01.016 to C.01.020 do not apply to drugs used for the purposes of a clinical trial.