法學期刊
論著名稱: 藥品嚴重不良反應通報義務之法律爭議(Issues on the Reporting Obligations of the Serious Adverse Reaction of the Experimental Research of New Medicament)
編著譯者: 王志嘉
出版日期: 2017.03
刊登出處: 台灣/月旦醫事法報告第 5 期 /18-32 頁
頁  數: 9 點閱次數: 491
下載點數: 36 點 銷售明細: 權利金查詢 變更售價
授 權 者: 王志嘉
關 鍵 詞: 人體研究人體試驗人體研究法嚴重不良事件或反應
中文摘要: 本文主要是探討人體研究中有關新藥品、新醫療器材及新醫療技術於發生嚴重不良事件或反應之通報規定與相關法律爭議。首先,以藥品優良臨床試驗準則探討新藥品嚴重不良事件或反應、的定義與通報。其次,探討新醫療技術以及新醫療器材,對於「嚴重不良事件或反應通報」與新藥品通報所產生的歧異以及容易混淆之處。最後,針對新藥品的通報與新醫療技術及新醫療器材的歧異處,如「預期性的藥品嚴重不良反應」及「非預期性的藥品嚴重不良事件」是否需要通報等爭議,從人體研究受試者保護的精神以及法律解釋等提出建議。
英文關鍵詞: human researchhuman trialsHuman Subjects Research Actserious adverse event or reaction
英文摘要: The purpose of this article was to discuss the obligation to report the serious adverse event(SAE)or serious adverse reaction(SAR)and related legal issues on the experimental research of new medical technology, new medicament, and new medical implement. First, the definition and bulletin of the SAE or SAR of the experimental research of new medicament are discussed by using the Regulations for Good Clinical Practice(GCP). Then, the differences and confused concepts of the bulletin of the experimental research of new medical technology and new medical implement are compared with those of the bulletin of the experimental research of new medicament. Finally, we provide suggestions for the obligation to report the expected serious adverse reaction and unexpected serious adverse event on the experimental research of new medicament based on the viewpoints of the protection of the human research participants and the interpretations of the law.
目  次: 壹、前言
貳、新藥品嚴重不良事件或反應的定義與通報
參、新醫療技術與新醫療器材的通報規定
肆、新藥品不良事件或反應通報的爭議
伍、結論
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