篇名

特定細胞治療技術法規簡介   免費試閱

並列篇名

Introduction of Regulations Governing Specific Cellular Therapeutic Technology

作者
中文摘要

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。

英文摘要

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.

起訖頁

007-019

出版單位
DOI

10.3966/241553062018110025001  複製DOI  DOI查詢

QRCode

數位整合服務
產品服務
讀者服務專線:+886-2-23756688   傳真:+886-2-23318496   地址:臺北市館前路28號7樓

Copyright © 元照出版 All rights reserved. 版權所有,禁止轉貼節錄
TOP