title: Status quo of management of the human tissue banks in Taiwan.
abstract: As the technologies associated with transplantation and biological tissue engineering continue to advance, human cells and tissues form an integral part to the practice of regenerative medicine. The patient's use of tissues entails the risk of introducing, transmitting and spreading communicable diseases. To prevent such risk and to ensure that the human organs, tissues and cells remain intact and functional after being handled and processed, the transplanted tissues must be subject to good management standards through all stages of collection, screening, processing, storage and distribution as the safety of the users is of the utmost importance. On February 2009, the government of Taiwan promulgated the Regulations for Administration on Human Organ Bank that requires all human tissues banks to adhere to the Good Tissue Practice for Human Organ, Tissue and Cell in terms of establishment and operation in order to cope with the international management trend and the development and management need of the domestic industry. Six years have passed since the law became effective. This article seeks to introduce the current management mechanism and status quo of management of human tissue banks in Taiwan. We also conducted statistical analysis of the data relating to the tissue banks to identify potential risks and the room for improvement. The study concludes that human tissue banks in Taiwan are on the right track with their management practice, leading to a state of steady development and progress.
authors.affiliation: Division of Risk Management, Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 115-61, Taiwan, ROC.
authors.forename: Ching-Pang
authors.initials: CP
authors.lastname: Chou
authors.affiliation: Division of Risk Management, Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 115-61, Taiwan, ROC. xo238428@gmail.com.
authors.forename: Szu-Cheng
authors.identifier: http://orcid.org/0000-0001-9788-3687
authors.initials: SC
authors.lastname: Chou
authors.affiliation: Division of Risk Management, Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 115-61, Taiwan, ROC.
authors.forename: Ying-Hua
authors.initials: YH
authors.lastname: Chen
authors.affiliation: Division of Risk Management, Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 115-61, Taiwan, ROC.
authors.forename: Yu-Hsuan
authors.initials: YH
authors.lastname: Chen
authors.affiliation: Division of Risk Management, Food and Drug Administration, Ministry of Health and Welfare, No.161-2, Kunyang St, Nangang District, Taipei City, 115-61, Taiwan, ROC.
authors.forename: Ming-Shin
authors.initials: MS
authors.lastname: Lee
mesh_terms: D006801:Humans; D013624:Taiwan; D014015:Tissue Banks / Q000458:organization & administration / Q000592:standards*; D009927:Tissue and Organ Procurement / Q000458:organization & administration / Q000592:standards; D019737:Transplants / Q000592:standards
keywords: HCT/Ps; Human tissue banking; Regenerative medicine