儿童药物研发鼓励政策研究

中国药物警戒 ›› 2014, Vol. 11 ›› Issue (12): 746-748.

儿童药物研发鼓励政策研究

许顺贵,刘春光

武警北京市总队医院药剂科，北京100027

收稿日期:2014-07-06 修回日期:2016-02-03 出版日期:2014-12-08 发布日期:2016-03-02
作者简介:许顺贵，男，本科，主管药师，临床药学。

Study on Incentive Policy for Pediatric Drug Research and Development

XU Shun-gui, LIU Chun-guang

Department of Pharmacy, Beijing Armed Police Corps Hospital, Beijing 100027,China

Received:2014-07-06 Revised:2016-02-03 Online:2014-12-08 Published:2016-03-02

摘要/Abstract

摘要： 目的儿童药物缺乏是国内外普遍现象，完善儿童药物研发鼓励政策是解决儿童药物短缺的有效方式，通过儿童药物研发鼓励政策研究，提出适合我国儿童药物研发的鼓励措施。方法检索WHO、欧美等国药品监管官方网站，梳理国外儿童用药鼓励研发的先进做法，分析我国儿科药物研发鼓励现状，并提出建议。结果与结论我国儿童药物研发鼓励政策应建立并完善儿童药物临床试验的法规，促进儿科药物适宜剂型的研发，推动更多儿童药物进入我国基本药物目录，并增进多部门联合协作。

关键词: 儿童药物, 鼓励政策

Abstract: Objective The lack of pediatric drug is a common phenomenon at home and abroad. Improving the incentive policy for pediatric drug is an effective way to solve the shortage of drug for children. In this paper, through the analysis of research and development for the incentive policy of pediatric drug, put forward the incentive mechanism for suitable pediatric drug in China. Methods Search the official websites of WHO, FDA and MHRA, combining with the foreign advanced approaches for development of pediatric drug. And analyze the present situation and the problems in the pediatric drug development to offer proposals. Results and Conclusion We should pay attention to improve the legal framework of clinical trials in children, promote the development of suitable pediatric drug formulations, screen more pediatric drugs into the Essential Medicine List, and strengthen multi-sectoral joint collaboration.

Key words: pediatric drug, incentive policy

中图分类号:

许顺贵,刘春光. 儿童药物研发鼓励政策研究[J]. 中国药物警戒, 2014, 11(12): 746-748.

XU Shun-gui, LIU Chun-guang. Study on Incentive Policy for Pediatric Drug Research and Development[J]. Chinese Journal of Pharmacovigilance, 2014, 11(12): 746-748.

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