奈米醫療對藥物查驗登記制度之衝擊－美國與我國之比較

Impacts-of Nanomedicine on Premarket Approval Applications in United States and Taiwan

陳鋕雄(Chih-Hsiung Chen) ； 陳鵬元(Peng-Yuan Chen)

《醫事法學》 18卷1期 (2011/06) Pp. 1-20

摘要

奈米材料之快速發展帶動了奈米醫療朝高度整合之方向邁進，未來將爲台灣食品藥物管理局帶來重大衝擊。鑒於奈米科學與應用技術將進入量子物理學領域，而與傳統巨觀下之古典牛頓力學有別，更挑戰著美國食品藥物與化妝品法於1938年沿用至今，並爲我國所繼受之舊有分類管制架構－物理、化學作用二分法。另，奈米藥品因具備新穎特性，故是否應歸屬新藥品於我國亦生有爭議。因此，本文將分析美國食品藥物管理局現有查驗登記產品、新藥分類架構，並檢視我國現有管制架構是否足以因應奈米醫療特有、未可知之風險，並提出修法建議。

關鍵字

奈米醫療 ； 奈米技術 ； 奈米材料 ； 查驗登記 ； 學名藥

並列摘要

The diversity and rapid development of nanomaterials are leading nanomedcine into a highly interdisciplinary era and bringing foreseeable enormous impacts on TFDA. As nanoscience and nanotechnology apply the rules of Quantum Mechanics rather than Classical Newtonian Mechanics, they are forcing legislators and FDA reconsidering U.S. Federal Food, Drug and Cosmetic Act, which have assigned drugs as the category that acts chemically and devices as the one that acts physically or mechanically since 1938. TFDA approves NDA and IDE under the same dichotomy, which is no longer distinguishable in Quantum Mechanics, and faces the same classification difficulties. Further, this article found nanodrug as a new drug in U.S. may be classified as generic drugs in Taiwan bringing a loophole in safety review. As a result, we propose a reconstruction of classification in Taiwan.

並列關鍵字

Nanomedicine ； Nanotechnology ； Nanomaterials ； PMA ； Generic Drug

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