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
You may also be interested in...
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.
Irish Body Sets Out Five-Year Vision Strategy For Off-Patent Sector
With a focus on drug accessibility, supply chain resilience, and a balanced approach to sustainability, Medicines for Ireland “calls to action” with its five-year plan.
Post-Brexit UK Risks Being ‘Left Out In The Cold’ As EU Coordinates Action On Shortages
The UK is not alone in experiencing drug shortages, as data from across Europe show, but its departure from the EU makes it more difficult to respond to supply chain pressures, according to new research.