Regulations for Reporting Serious Adverse Reactions of Medicaments Article 9
Upon becoming aware of a serious adverse drug reaction, pharmaceutical firms shall proactively investigate and assess the causal relationship associated with the reported information.If pharmaceutical firms discover a serious adverse drug reaction that occurs at an unexpected or higher-than-expected frequency or if it is necessary to add or change contraindications or usage restrictions based on the investigation and assessment results under the preceding paragraph, the matter shall be handled according to Article 6 of the Regulations for the Management of Drug Safety Surveillance.
中文原文 嚴重藥物不良反應通報辦法第9條
藥商知悉藥品嚴重不良反應時，應主動調查及評估通報資料之成因相關性。
藥商依前項調查及評估結果，發現未預期或超出預期發生頻率之藥品嚴重不良反應，或有新增或變更禁忌、使用限制之必要者，應依藥品安全監視管理辦法第六條規定辦理。
藥商依前項調查及評估結果，發現未預期或超出預期發生頻率之藥品嚴重不良反應，或有新增或變更禁忌、使用限制之必要者，應依藥品安全監視管理辦法第六條規定辦理。