Subsequent to the new legislation of Regenerative Medicine Promotion Act on April 26, 2013, Act on the Safety of Regenerative Medicine and the Pharmaceuticals, Medical Devices Act (PMD.Act) Pharmaceutical Affairs Act came into force on November 25, 2014. Due to the particular nature of “regenerative medicine products” using cells for therapies, fast-track approval system was introduced in the said Act. The Act on the Safety of Regenerative Medicine enabled medical institutions to outsource cell culturing and processing to companies.
For the purpose of promoting stable manufacturing of cell sheet products, CellSeed has constructed a Cell Processing Facility to manufacture cell sheet products, and acquired the "Manufacturing Business Accreditation" from Ministry of Health, Labour and Welfare. (Facility Number:FA3160008)