Title

人體器官保存庫管理現況

Translated Titles

The Management Status of Human Tissue Banks in Taiwan

DOI

10.6945/ARFDR.201112.0053

Authors

周清邦(Ching-Pang Chou);翁偉雄(Wei-Hsiung Weng);楊若英(Ruoh-Ing Yang);陳惠芳(Hwei-Fang Cheng)

Key Words

人體器官保存庫 ; 組織工程 ; 風險 ; human tissue bank ; tissue engineering ; risk

PublicationName

食品藥物研究年報

Volume or Term/Year and Month of Publication

2期(2011 / 12 / 08)

Page #

51 - 58

Content Language

繁體中文

Chinese Abstract

人體幹細胞研究與生物組織工程技術的進步,使移植用人體器官、組織與細胞之採集、篩檢、處理、儲存、培養與配送,已逐漸在許多國家發展成一種新興跨領域技術的生物科技產業,然而人體細胞組織物作為醫療產品的最大風險,來自於這些產品可能帶有傳染病病原,其次則為在處理過程中因不當操作導致污染,進而影響這些人體細胞組織物的完整性與效用。為因應使用人體細胞組織而衍生之管理需求,美國食品藥物管理局生物製劑評估研究中心已於2005年5月25日正式公告實施 Code 21 CFR 1271法案,將人體細胞組織物納入管理,並以Current Good Tissue Practice作為人體細胞組織物自採集、處理至運送等各階段的管制依據。我國為因應國際最新管理趨勢並兼顧國內產業發展管理需要,亦於98年2月正式公告「人體器官保存庫管理辦法」,其中第十二條條文規範保存庫之設置及運作,應符合人體器官、組織及細胞優良操作規範,作為國內從事人體器官、組織及細胞之研發、製造機構的管理規範。由開始接受設置申請至99年底為止共有111家人體器官保存庫提出設置申請,完成99家人體器官保存庫設置計畫審查。受理83家人體器官保存庫實地履勘申請,累積完成48家人體器官保存庫實地履勘,並有28家人體器官保存庫取得許可。為有效提升國內從事人體器官保存機構的品質,本局將持續執行人體器官保存庫符合性評鑑處理作業建立其設置登記驗證體系,以確保器官、組織及細胞接受者安全。

English Abstract

The progress of human stem cells research and tissue engineering has gradually boosted the recovery, screening, processing, storage, culture and distribution of human organs, tissues and cells used in transplant, into an emerging interdisciplinary biotechnological industry in many countries. However, the biggest risk for human tissue is the introduction, transmission or spread of communicable diseases caused by improper processing. These risks affect its integrity and effectiveness. In order to fulfill the management requirement for human tissue usage, the Center for Biologics Evaluation and Research of U.S. Food and Drug Administration has formally announced Code 21 CFR 1271 on May 25, 2005, along with the current good tissue practice for administering collection, process and transport of human cells and tissues accordingly. Due to the latest international management trends and needs for domestic industry, Department of Health, Taiwan has formally announced regulations for administration on human organ bank in Feb. 2009, in which article 12: ”The establishment and operation of an organ bank shall comply with the rules of good human organ, tissue and cell practice” is the guideline for establishments in research and manufacture to follow. As of the end of 2010, 111 organ banks have filed application, 99 have been reviewed, 83 have applied for on-site inspection, 48 have been inspected, and 28 have been approved. To promote the quality of establishments in human organ bank, Taiwan Food and Drug Administration will continually conduct the conformity identification process and set up the registered certification system, so as to ensure the safety for recipient to accept organs, tissues and cells.

Topic Category 醫藥衛生 > 藥理醫學
Times Cited
  1. 劉韋博(2015)。生技製藥產業創新技術之價值創造模式-以新興細胞治療公司為例。臺灣大學財務金融組學位論文。2015。1-92。 
  2. 劉姿吟(2010)。臍帶血保存契約之研究。臺灣大學科際整合法律學研究所學位論文。2010。1-90。