POLICY AND PRACTICE REVIEWS article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1600207
A Comparison of the Labeling of Antineoplastic and Supportive Medicines in China, Japan, and the US Based on the WHO Essential Medicines List
Provisionally accepted
- School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China
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Objective: This study systematically compares the safety information presented on drug labels for antineoplastic and supportive care medications listed on the WHO Essential Medicines List (EML) across three major pharmaceutical markets: China, Japan, and the United States. Methods: The safety information of the same drugs approved in the three countries was compared and analyzed, involving the calculation of the proportion of each safety information and the percentage of boxed warnings (PBW) to all information on the label, we also comparative analysis of pediatric medication information studied from each country. Results: There were substantial differences in each safety information of the labels in three countries. Except for the proportion of information on use in the elderly, the proportion of each type of safety information differed significantly between countries, and the content also varied widely. Concordance of the presence or the absence of a BW on the label between China, Japan, and the US was 36% on the total labels. Of the 19 drugs, Japan had the most pediatric drug information with 13 drugs, followed by the US with nine drugs and China with eight drugs. Conclusion: There were significant differences in the safety information on drug labels in China, Japan, and the US from the same manufacturer, which could pose a risk to patients. Regulatory agencies should better align their approaches to labeling to prevent confusion or misunderstanding across regions.
Keywords: Drug labels, antineoplastic and supportive medicines, NMPA, PMDA, fda
Received: 09 Apr 2025; Accepted: 29 Sep 2025.
Copyright: © 2025 Du, Wang and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Pengcheng Liu, 1020122252@cpu.edu.cn
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