Both foreign and domestic companies are benefitting from Japan’s revised classification system that was implemented in November 2014. The new classification system separated regenerative medical products from medical devices and streamlined the approval process. Rather than undergo a lengthy clinical trial process that could take many years, foreign manufacturers can now do a shorter clinical trial period before receiving conditional approval. This conditional approval allows companies to quickly put their product on the market. Additional data collected during this post-market period will be used when a foreign manufacturer applies for final approval from Japan’s regulatory agency.
These regulatory changes have advanced Japan’s burgeoning regenerative medicine industry. Regenerative medicine utilizes stem cell treatments and gene therapy to restore functionality to damaged organs and tissues. While research into stem cell treatment and gene therapy has faced considerable setbacks in the U.S. and other Western countries, Japan has pushed forward with new research. Japan’s regulatory modifications have only further cemented the country as a leader in regenerative medicine globally.
According to Nikkei Asian Review, Adipo Medical Technology (Higashi, Osaka) is one of the domestic companies set to benefit from improved laws. The company has focused its research on treating heart issues with regenerative cell technology and has plans to start clinical trials for its new products in early 2016.
Another Japanese company, Nikon Corporation, has teamed up with Swiss chemical and biotechnology company Lonza in a bid to enter the regenerative market. The two companies are planning to combine their efforts to cultivate cells and become a major supplier. Success will ensure that research institutes and doctors will have access to a reliable source of pluripotent stem cells. Pluripotent stem cells are valuable because they potentially produce any cell or tissue the body needs to repair itself.
Japan’s Ministry of Economy, Trade, and Industry has estimated that the Japanese market for regenerative treatments will be worth nearly USD $13 billion by 2030.