New regulations accelerating the approval of regenerative therapeutics in Japan took effect Nov. 25, 2014, propelling that nation onto the radar screens of life sciences companies around the world. The chief benefit of these new rules is that they enable companies to receive conditional marketing approval and generate revenue from regenerative products while trials are being conducted.
"A lot of people here (in the U.S.) don’t know about it,” says Gil Van Bokkelen, Ph.D., CEO and chairman of Athersys and ex officio chair of the Alliance for Regenerative Medicine. “As more visibility and tangible progress is generated, I think it will create a lot of additional interest and excitement.”
The acceleration of regenerative medicine development and commercialization is part of the economic revitalization plan – “Abenomics” – launched by Prime Minister Shinzō Abe in 2012. That plan also includes ¥110 ($1 billion) in funding for stem cell research.