特定細胞治療技術法規簡介【本期企劃】 試閱
Introduction of Regulations Governing Specific Cellular Therapeutic Technology
衛生福利部於2018年9月6日公告修訂「特定醫療技術檢查檢驗儀器施行或使用管理辦法」,將六種安全性可確定、成效可預期之細胞治療項目,納入特定醫療技術管理,預期對臺灣的細胞治療發展將產生顯著的影響。修訂後之管理辦法針對細胞治療設有新的特別規定,本文將扼要解析這些規定,並提出一些尚待釐清之疑問,協助讀者了解這項新規範。
Ministry of Health and Welfare has amended the "Regulations Governing Implementation or Use of Specific Medical Technology, Examination, Laboratory Testing and Ministry Devices” on September 6, 2018. Six items of cellular therapy deemed with ascertain safety and expectable efficacy were listed. This new regulation is expected to have significant impact on the development of cellular therapies in Taiwan. In this article, these provisions will be elucidated and some issues will be discussed to help readers have better understanding of this new regulation.
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