title: First Approval of Regenerative Medical Products under the PMD Act in Japan.
authors.affiliation: Medical Device and Regenerative Medicine Product Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour, and Welfare, 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-8916, Japan.
authors.forename: Akihide
authors.initials: A
authors.lastname: Konishi
authors.affiliation: Pharmaceuticals and Medical Devices Agency, 3-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan. Electronic address: sakushima-ken@umin.ac.jp.
authors.forename: Ken
authors.initials: K
authors.lastname: Sakushima
authors.affiliation: Medical Device and Regenerative Medicine Product Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour, and Welfare, 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-8916, Japan.
authors.forename: Soichiro
authors.initials: S
authors.lastname: Isobe
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: D064987:Cell- and Tissue-Based Therapy / Q000379:methods; D002986:Clinical Trials as Topic; D006086:Graft vs Host Disease / Q000628:therapy; D006333:Heart Failure / Q000628:therapy; D006801:Humans; D007564:Japan; D062307:Medical Device Legislation; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence / Q000379:methods; D013234:Stem Cells