title: [Development and evaluation of new drugs and medical devices in Japan--standpoint of regulatory agency].
authors.affiliation: Pharmaceuticals and Medical Devices Agency (PMDA), 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Maruyama
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Kondo
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006077:Government Agencies; D007564:Japan