임상시험에 사용되는 의약품의 임의의 용량에서 발생한, 모든 유해하고 의도되지 않은 반응으로서, 임상시험에 사용되는 의약품과의 인과관계를 배제할 수 없는 경우

Any noxious and unintended response associated with the use of a drug In humans.

① Post-approval: an adverse event that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.

② Pre-approval: an adverse event that occurs at any dose and where at any dose and where a causal relationship is at least a reasonable possibility.