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

• Published in: Clinical pharmacology and therapeutics Vol. 98; no. 5; p. 480
• Main Authors: Tanaka, A, Asano, K, Uyama, Y
• Format: Journal Article
• Language: English
• Published: United States 01.11.2015
• Subjects: Drug Approval - methods; Drug Labeling - methods; Drug Labeling - standards; Ethnic Groups - ethnology; Humans; Japan - ethnology; Multicenter Studies as Topic - methods; Multicenter Studies as Topic - standards; United States - ethnology; United States; Japan
• ISSN: 1532-6535
• DOI: 10.1002/cpt.197

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.