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Japan Issues New Guidance On Regenerative Medicine

This article was originally published in PharmAsia News

Executive Summary

To encourage development of treatments and medical devices in the Regenerative Medicine area, Japan's Ministry of Health, Labor and Welfare issued new guidance regarding quality and safety in RM development. A follow-up to previous guidance issued in 2000, the new guidance listed points for donor selection, screening of rejections, virus deactivation and removal, and quality management in cellular reproduction. Regarding autologous cells, the guidance calls for individualized measures to prevent confusion and cross contamination. In October 2007, autologous cultured epidermis JACE made by Aichi-based Japan Tissue Engineering Co., received government approval to treat serious burns. (Click for more-Japanese language
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