title: How should ethnicity-related information be included on drug labels? Considerations based on comparison of multiregional clinical trial data on the label between Japan and the United States.
abstract: Clinical data on various ethnicities collected in multiregional clinical trials (MRCTs) have increased in regulatory review for drug approval. However, how such data should be included on the drug labels has not been discussed. We compared information related to ethnicities on the labels of drugs that were approved in both Japan and the United States, and discussed the issues to be considered for providing better information to healthcare professionals in this era of globalized drug development.
authors.affiliation: Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.
authors.forename: A
authors.initials: A
authors.lastname: Tanaka
authors.affiliation: Office of New Drug I, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Asano
authors.affiliation: Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.|Department of Regulatory Science of Medicine, Graduate School of Medicine, Chiba University, Chiba, 260-8670, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Uyama
mesh_terms: D017277:Drug Approval / Q000379:methods*; D004348:Drug Labeling / Q000379:methods* / Q000592:standards; D005006:Ethnicity / Q000208:ethnology*; D006801:Humans; D007564:Japan / Q000208:ethnology; D015337:Multicenter Studies as Topic / Q000379:methods* / Q000592:standards; D014481:United States / Q000208:ethnology