国外儿童用药研发与应用监管政策分析

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (9): 527-532.

国外儿童用药研发与应用监管政策分析

卢玉美

沈阳药科大学工商管理学院,辽宁沈阳 110016

收稿日期:2013-06-14 修回日期:2016-03-09 出版日期:2013-09-08 发布日期:2016-03-09
作者简介:卢玉美,女,在读硕士,药品政策法规。

Analysis of Foreign Regulatory Policy for Pediatric Research and Development and Application

LU Yu-mei

Business School of Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2013-06-14 Revised:2016-03-09 Online:2013-09-08 Published:2016-03-09

摘要/Abstract

摘要： 儿童正处于发育时期,与成人用药存在很大区别,其用药安全问题不可忽视。我国儿童用药市场尚未成熟,国家未出台相应的法规政策专门指导儿童用药,这在一定程度上增大了儿童用药的风险。美国和欧盟已在此方面做出努力,建立儿科独占制度鼓励企业进行儿科研究,日本、WHO以及其他地区也制定相应措施,促进儿童用药研发与监管。本文参考国内外文献,对美国和欧盟儿童用药研发和应用监管政策进行研究、分析,以对我国儿童用药政策的制定提供建议。

关键词: 国外, 儿童用药, 研发, 监管, 政策

Abstract: Children are in the developmental stages, and there is a big difference between the drugs for children and drugs for adult, so drug safety issues can not be ignored. Our market for drugs in children is not yet mature, and there are not relevant regulations and policies to specifically guide the drug use in children, which to some extent increases the risk of pediatric drugs. The U.S. and the EU have made great efforts in this regard, established the pediatric exclusive system to encourage enterprises to conduct pediatric research. Japan, WHO and other regions developed appropriate measures to promote the development of pediatric drug research and supervision. Based on the literatures home and abroad, we analyzed the regulatory policies for the research and development and application of pediatric drugs in U. S. and EU in order to provide recommendations for our drug policy.

Key words: foreign, pediatric drugs, research and development, supervision and regulation, policies

中图分类号:

R951

卢玉美. 国外儿童用药研发与应用监管政策分析[J]. 中国药物警戒, 2013, 10(9): 527-532.

LU Yu-mei . Analysis of Foreign Regulatory Policy for Pediatric Research and Development and Application [J]. Chinese Journal of Pharmacovigilance, 2013, 10(9): 527-532.

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