Regulations for Reporting Serious Adverse Reactions of Medicaments Article 2
The term “serious adverse reaction to drugs,” as used in these Regulations, shall refer to the use of a drug resulting in the occurrence of one of the conditions listed in the following subparagraphs:1. Death;2. Life-threatening condition;3. Permanent disability;4. Congenital anomaly/birth defect of fetus/infant;5. Inpatient hospitalization or prolongation of existing hospitalization;6. Other complications that may result in permanent injuries.
中文原文 嚴重藥物不良反應通報辦法第2條
本辦法所稱藥品嚴重不良反應，指因使用藥品致生下列各款情形之一者：
一、死亡。
二、危及生命。
三、永久性殘疾。
四、胎兒、嬰兒先天性畸形。
五、病人住院或延長病人住院時間。
六、其他可能導致永久性傷害之併發症。
一、死亡。
二、危及生命。
三、永久性殘疾。
四、胎兒、嬰兒先天性畸形。
五、病人住院或延長病人住院時間。
六、其他可能導致永久性傷害之併發症。