再生醫療製劑應用之規範探討-以免疫細胞治療CAR-T 為例

Abstract

再生醫療是近 10 年來發展出來的新興治療方式，讓原本已經對眾多治療藥品不見起色的病患，開啟了另外一扇窗。 本論文研究了再生醫療(以 CAR-T 產品為例) 在歐洲與美國的發展，舉凡法規面、臨床試驗發展、適應症研發、開發藥廠的分布以及製造流程等。有了美國再生醫療管理的前車之鑑，分析了台灣目前在再生醫療法規的建置，進而展望未來的再生醫療雙法。

Regenerative medicine was a novel therapy in the past decade, providing another opportunity for patients who did not improve after the available medicines. In this study, we analyze the progress of regenerative medicine ( take CAR-T product as an example) in Europe and United States, including the regulations, clinical trials, indication, distribution of the pharmaceutical companies and manufacturing process. With the experience from United States, we identified the opportunity of Taiwan current regulation of regenerative medicine and further analyze the possibility to improve Taiwan regulation of regenerative medicine management.