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·药事管理·

美国儿童药品上市审批情况分析及其对我国儿童用药保障工作

的启示 Δ

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王雅君 1，2＊ ，韩 容 ，岳志华 ，许馨文 ，赵志刚 （1.首都医科大学附属北京天坛医院药学部，北京 100070；2.
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首都医科大学药学院，北京 100069；3.国家药典委员会化药处，北京 100061；4.中国医药新闻信息协会儿童
安全用药分会秘书处，北京 101200）
中图分类号 R95；R985 文献标志码 A 文章编号 1001-0408（2021）02-0133-06
DOI 10.6039/j.issn.1001-0408.2021.02.02

摘 要 目的：为完善我国儿童药品品种、保障儿童用药安全提供借鉴。方法：总结美国在儿童药品上市审批方面的政策法规历
史沿革及相关政策实施效果；结合我国儿童药品发展现状，提出保障我国儿童用药可及性和安全性的相关建议。结果与结论：美
国自1994年起就出台了一系列的政策法规以鼓励发展儿童药品，目前其儿童药品上市审批主要依据《最佳儿童药品法》（BPCA）
和《儿科研究平等法》（PREA）两部法律。1998－2019 年，美国药品说明书儿童用药信息的补充数量总体呈现波动性增长；截至
2020年4月，已经有854种药品进行了儿科说明书的修改，其中792种药品进行了上市后儿科临床研究，其儿科说明书信息不全等
问题得到了很大改善。目前，我国对儿童药品制定的政策主要包括鼓励研发创新、优先审评审批，以及加强研发技术指导等，虽取
得了一定的成绩，但仍存在相关政策法规不完善、开展儿童药品临床试验困难较大等问题。建议我国借鉴美国儿童药品相关政策
法规、儿科研究及儿童药品目录，建立和完善适合我国国情的儿童药品制度和目录，提高儿童药品的安全性、有效性和可及性。
关键词 儿童药品；上市审批；政策法规；美国；启示

Analysis of the Marketing Approval of Pediatric Drugs in the United States and Its Enlightenment to
Pediatric Drug Use Guarantee in China
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WANG Yajun ，HAN Rong ，YUE Zhihua ，XU Xinwen ，ZHAO Zhigang（1. Dept. of Pharmacy，Beijing
1，2
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Tiantan Hospital，Capital Medical University，Beijing 100070，China；2. College of Pharmacy，Capital Medical
University，Beijing 100069，China；3. Dept. of Chemical Drug，Chinese Pharmacopoeia Commission，Beijing
100061，China；4. Dept. of Secretariat，Safe Medication for Children Branch of China Medical News and
Information Association，Beijing 101200，China）
ABSTRACT OBJECTIVE：To provide suggestions for improving the variety of pediatric drugs and ensuring the safety of
pediatric drug use in China. METHODS：The historical evolution of laws and regulations on the marketing approval of pediatric
drugs in the United States and the implementation results of relevant policies were summarized. Combined with the current situation
of the development of pediatric drugs in China，some suggestions were put forward to ensure the accessibility and safety of
pediatric drug use in China. RESULTS & CONCLUSIONS：Since 1994，the United States had issued a series of laws and
regulations to encourage the development of pediatric drugs. At present，the marketing approval of pediatric drugs were mainly
based on the two laws of Best Pediatric Drug Act（BPCA）and Pediatric Research Equality Act（PREA）. From 1998 to 2019，the
amount of supplements of pediatric drug information in drug instructions of the United States showed a fluctuating growth. As of
April 2020，854 kinds of drugs had been modified in pediatric instructions，792 of which had been carried out post marketing
pediatric clinical research，and the problem of incomplete pediatric instructions had also been greatly improved. At present，China’s
policies on pediatric drugs mainly included encouraging R&D innovation，giving priority to review and approval，and strengthening
R&D technical guidance. Although certain achievements had been made，there were still some problems，such as imperfect policies
and regulations，and great difficulties carrying out pediatric drug clinical trials. It is suggested that our country should draw lessons
from the American regulations on pediatric drugs，pediatric research and the catalogue of pediatric drugs，and establish a system
and catalogue of pediatric drug use suitable for China’s national conditions，so as to improve the effectiveness，safety and
accessibilityof pediatric drugs.
Δ 基金项目：国家科技重大专项项目（No.2018ZX-09721003）
＊硕士研究生。研究方向：临床药学。E-mail：18810956566@ KEYWORDS Pediatric drugs；Marketing approval；Policy
163.com and regulation；the United States；Enlightenment
# 通信作者：主任药师，教授，博士生导师。研究方向：临床药学
和药事管理。电话：010-59978036。E-mail：1022zzg@sina.com

中国药房 2021年第32卷第2期 China Pharmacy 2021 Vol. 32 No. 2 ·133 ·