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1.
Cell Tissue Bank ; 18(1): 69-73, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27837287

RESUMO

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.


Assuntos
Bancos de Tecidos/normas , Humanos , Taiwan , Bancos de Tecidos/organização & administração , Obtenção de Tecidos e Órgãos/organização & administração , Obtenção de Tecidos e Órgãos/normas , Transplantes/normas
2.
J Food Drug Anal ; 22(4): 399-406, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28911452

RESUMO

The Food and Drug Administration in Taiwan is responsible for the quality regulation and control of cosmetics. In order to have a clear understanding of the trends in the product quality monitoring outcomes and the regulatory control measures over the past years, this study has put together the reports of nine cosmetic surveillance projects conducted between 1982 and 2012. The findings can be used as a reference in developing a more solid quality monitoring plan and management system for cosmetic products. Results show that permanent wave products, hair dye products, and phthalate esters in cosmetic products have the highest average noncompliance rates at 39.2%, 14.2%, and 11.2%, respectively. These are followed by the average noncompliance rates of mercury in products, sunscreen products, and microorganisms in products, at 8.5%, 7.1%, and 5.5%, respectively, and the remaining three projects averaging below 4.1%. Since 1997, when new standards were announced and assistance to manufacturers was reinforced, the noncompliance rates of permanent wave products decreased annually, until 2007, when it was fully qualified for the standards. Overall, the study showed that the noncompliance rates of permanent wave products and for levels of phthalate esters, mercury, and hydroquinone in cosmetic products have all decreased in the previous years. The results of surveillance projects conducted after 2005 revealed only one noncompliance sample with lead, arsenic, and cadmium, whereas the surveillance projects on permanent wave products and chloroform- and 1,4-dioxane-containing products revealed full compliance with regulation standards. However, the noncompliance rates for microorganisms in cosmetics and the ingredients in hair dye products and sunscreen products were still high. These high-risk products must be monitored. These surveillance projects are conducted to ensure the safety of cosmetics in the market.

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