Japan Tissue Engineering’s Cultured Cartilage Approval Gets Delayed
This article was originally published in PharmAsia News
Executive Summary
Aichi-based regenerative venture company Japan Tissue Engineering announced March 13 that manufacturing and marketing approval in Japan for its autologous cultured cartilage has been delayed to 2010. J-TEC hoped for an approval within this fiscal year ending September. Japan's regulatory agency Pharmaceutical and Medical Device Agency informed the company during a pre-approval consultation. PMDA said the approval is still in progress. The Second regenerative product after autologous cultured epidermis JACE, J-TEC completed clinical trials for the cartilage product March 2007. (Click here for more - Japanese language