人體細胞組織物之查核管理

為預防因使用人體細胞組織物（human cell, tissue, and cellular and tissue-based products）而導入、傳播及擴散傳染病，降低使用人體細胞組織物的風險，並順應國際最新管理趨勢及兼顧國內產業發展管理需要，行政院衛生署於91年12月正式公告人體細胞組織優良操作規範（Good Tissue Practice, GTP），作為國內從事人體細胞組織物之研發、製造機構的管理規範。並於98年2月公告人體器官保存庫管理辦法，以作為國內從事人體器官、組織及細胞之處理或保存的規範。在體細胞治療人體試驗案GTP訪查部份，自94至100年止，共計完成64案之體細胞治療人體試驗案GTP訪查。而在人體器官保存庫部份，自98至100年止，共受理114家保存庫設置申請，並完成102家保存庫實地履勘，其中92家取得許可。未來將對體細胞治療實驗室及人體器官保存庫持續執行GTP符合性評鑑，以維護再生醫療之安全及品質。

關鍵字

人體細胞組織物；人體細胞組織優良操作規範；細胞治療；人體器官保存庫

並列摘要

The biggest risk for human cell, tissue, and cellular and tissue-based products (HCT/Ps) is the introduction, transmission or spread of communicable diseases caused by improper processing. These risks affect its integrity and effectiveness. In order to reduce the risk for HCT/Ps usage and to follow the latest international management trends, Department of Health, Taiwan formally announced good tissue practice (GTP) in Dec. 2002. The GTP is the guideline for establishments in research and manufacture to follow. The regulations for administration on human organ bank were then announced by Department of Health, Taiwan in Feb. 2009. It is the regulations for institutions that are engaged in the processing or preservation of human organs, tissues and cells for the purpose of transplantation to follow. Sixty-four human trials have been inspected according to GTP from 2005 to 2011. As of the end of 2011, 114 organ banks have filed application, 102 have been inspected, and 92 have been approved. To reduce the risk for HCT/Ps usage, Taiwan Food and Drug Administration will continually conduct the conformity identification process, so as to ensure the safety and quality for regenerative medicine.

並列關鍵字

human cell ； tissue ； and cellular and tissue-based products ； good tissue practice ； cell therapy ； human tissue bank

國際替代計量

人體細胞組織物之查核管理

全文下載

主題瀏覽