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KMID : 0922220100100010001
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Journal of the Korean Musculoskeletal Transplantation Society
2010 Volume.10 No. 1 p.1 ~ p.19
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The Study for Improvement of Regulatory System about Importing Human Tissues from Foreign Countries
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Song Baek-Yong
Awe Soo-Ik
Kim John
Yi Irene
Kim Soo-Yong
Jung Hyun-Song
Park Jamie
Park Hyun-Seon
Song Seok-Beom
Choi Woen-Ik
So Jung-Won
Kim Byoung-Seok
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Abstract
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Purpose: The purpose of this study was to improve new higher safety level of regulatory system about importing human tissues from foreign countries and provide its related informations to importers, including preparing the specific steps and methods of on site inspection.
Materials and Methods: The laws, regulations, acts, and provisions about human tissues were studied and reviewed by using of checking the website search and literature review. More informations were obtained through personal consultations with FDA officer and the presidents of AATB and EATB. And then, authors would grasp good and bad points of regulatory system about importing human tissues from other countries in domestic, the USA and Europe and try to prepare new regulatory system.
Results: No specific exporting and importing regulatory systems about human tissues are available in between EU countries, but they can freely export or import human tissues if it is registered in their country within EU countries. At the moment, exporting and importing human tissues in between EU countries and non EU countries is exercised by each country’s own regulations or laws. EU is currently in process of preparing regulatory system about importing human tissues into EU members. The regulation or laws of the USA for importing human tissues requires exporting tissue banks to register through the US FDA and then reviews any related documents of the human tissues coming into the USA. The US FDA may request indefinite amount of related documents and also may inspect the exporting tissue bank when necessary before clearing the human tissues to be distributed in the USA. The current domestic regulatory system about importing human tissues coming into Korea are similar to the USA, but we lack the requirement of registration and on site inspection of exporting tissue bank to KFDA.
Conclusion: It seems to be necessary to enforce all exporting tissue banks overseas to register at KFDA and KFDA should have provisions of punishments and penalties to those tissue banks violating laws of human tissue regulations. When necessary, KFDA may cancel the registration, to stop exporting any human tissues processed from non registered tissue banks to Korea. It is also necessary to inspect all foreign exporting tissue banks rather than reviewing documents alone which will soon help our citizens health by ensuring safe human tissues are imported into Korea.
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KEYWORD
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Importing, Human tissue, Improvement of regulatory system
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Listed journal information
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