title: New Japanese initiatives on stem cell therapies.
abstract: Two laws aiming to provide a new legal framework to promote regenerative medicine, while ensuring the efficacy and safety of the treatments, came into effect in Japan on November 25, 2014. The scope of these laws is briefly described here.
authors.affiliation: Research and Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare, 1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916, Japan. Electronic address: jzt02060@nifty.ne.jp.
authors.forename: Kenji
authors.initials: K
authors.lastname: Konomi
authors.affiliation: Research and Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare, 1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916, Japan.
authors.forename: Morikuni
authors.initials: M
authors.lastname: Tobita
authors.affiliation: Research and Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare, 1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-8916, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Kimura
authors.affiliation: Pharmaceuticals and Medical Devices Agency, 3-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan.
authors.forename: Daisaku
authors.initials: D
authors.lastname: Sato
mesh_terms: D003257:Consumer Product Safety; D033161:Government Regulation; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000331:legislation & jurisprudence*; D057026:Induced Pluripotent Stem Cells / Q000637:transplantation; D007564:Japan; D008103:Liver Cirrhosis / Q000628:therapy*; D057193:Medical Tourism; D009369:Neoplasms / Q000276:immunology / Q000628:therapy*; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence*; D033581:Stem Cell Transplantation / Q000331:legislation & jurisprudence*