title: Conditional approval: Japan lowers the bar for regenerative medicine products.
abstract: A new system for conditional approval of regenerative medicine products will allow products of undetermined efficacy to enter the Japanese market. The potential scientific, economic, and ethical implications of this program highlight the need for further discussion and refinement.
authors.affiliation: RIKEN Center for Developmental Biology, 2-2-3 Minatojima, Minamimachi Chuo-ku, Kobe, Japan. Electronic address: sipp@cdb.riken.jp.
authors.forename: Douglas
authors.initials: D
authors.lastname: Sipp
mesh_terms: D002986:Clinical Trials as Topic; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D019981:Health Care Sector / Q000331:legislation & jurisprudence*; D006801:Humans; D007349:Insurance, Health, Reimbursement; D007564:Japan; D039904:Pluripotent Stem Cells / Q000637:transplantation; D011358:Product Surveillance, Postmarketing; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence*; D033581:Stem Cell Transplantation / Q000191:economics / Q000331:legislation & jurisprudence*