title: Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.
abstract: Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.
authors.affiliation: Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Asano
authors.forename: A
authors.initials: A
authors.lastname: Tanaka
authors.forename: T
authors.initials: T
authors.lastname: Sato
authors.forename: Y
authors.initials: Y
authors.lastname: Uyama
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D006801:Humans; D038622:Internationality; D007564:Japan; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence*; D044469:Racial Groups