103－106年度台灣人體器官組織保存庫管理現況調查

Management Status of Human Tissue Banks in Taiwan, 2014-2017

隨著移植醫學以及生物組織工程技術的發展，人體細胞組織物已是再生醫學上不可或缺的一環。為配合國內生技與醫藥領域環境建構政策，行政院衛生署（現為衛生福利部）於91年12月13日公告「人體細胞組織優良操作規範（Good Tissue Practice, GTP）」，供操作人體細胞組織物之執行機構遵循。另，為預防移植用人體器官（含組織、細胞）於處理及儲存時遭受交叉污染而導致公共衛生之疑慮，我國於98年2月公告「人體器官保存庫管理辦法」以規範人體器官保存庫之設置及其運作皆應符合人體器官、組織及細胞優良操作規範，截至106年底共有112家保存庫取得許可。本研究將闡明我國目前管理機制、國內保存庫管理現況，並藉由103－106年度保存庫相關資料之統計分析以辨明可能的潛在風險與改善空間。未來將持續推動該辦法之符合性評鑑及辦理品質教育訓練，賡續為我國移植用器官、組織及細胞提升品質與為安全把關，以保障國民健康。 With the development of transplantation medicine and biological tissue engineering technology, human cells and tissues have become an indispensable part of regenerative medicine. In order to construct a friendly and healthy policy environment for the bio-industry, Taiwan Department of Health (now the Ministry of Health and Welfare), announced the Good Tissue Practice (GTP) on December 13, 2002. Also, in order to reduce the risk of using human cell, tissue, and cellular and tissue-based products (HCT/ Ps), and to follow international management trends, the ＂Regulations for Administration on Human Organ Bank＂ as announced by the Taiwan Department of Health in February 2009 states in Article 12 that: ＂The establishment and operation of human tissue bank shall comply with the rule of Good Human Organ, Tissue and Cell Practices＂. In this article, we reviewed the management mechanism and current status of human tissue banks in Taiwan, and identified potential risk and problems to be improved as indicated by statistical analysis of date from 2014 to 2017. Up to the end of 2017, 112 tissue banks have been approved. TFDA will continually maintain the licensure system for human tissue banks, so as to ensure the safety of organ and tissue transplantation for recipients.