1103 細胞・組織加工製品に関する承認審査の動向(OS13-(5)オーガナイズドセッション《生体医工学及びバイオマテリアル》)

概要

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Cells/tissue-processed products have a high potential in the treatment of various diseases where there is a previously unmet medical needs. The use of these products should be confined to medical treatments where a clinical advantage over other products/treatments is expected, because the potential risk of the transmission of infectious agents or of other unknown factors derived from them can not be completely ruled out. For this purpose, the guideline of human cells/tissue-processed products to ensure their basic quality and safety before the clinical trial was established in 2000. Recently, autologous cultured epidermis was approved in October, 2007 through the review processes within the Pharmaceutical Affairs Law of Japan. It is the first medical device of processed human cellular/tissue product in Japan. Furthermore, guidelines on ensuring quality and safety of products derived from processed autologous/allogeneic human cells/tissues were set in 2008. Pharmaceuticals and Medical Devices Agency (PMDA) that is a Japanese regulatory agency working together with Ministry of Health, Labour and Welfare of Japan, performs reviewing the applied cells/tissue-based products. Here the current trends on review of cells/tissue-processed products in Japan are demonstrated.
一般社団法人日本機械学会の論文
2010-08-27