Overview of China′s pediatric drug situation and regulatory policy
10.13220/j.cnki.jipr.2016.04.001
- VernacularTitle:中国儿童用药现状及监管政策概述
- Author:
Hongjie XIAO
;
Mengdie ZHOU
;
Yang SUN
;
Wu ZHONG
- Publication Type:Journal Article
- Keywords:
pediatric drugs;
situation;
regulatory policy;
comparative;
suggestion
- From:
Journal of International Pharmaceutical Research
2016;43(4):579-584
- CountryChina
- Language:Chinese
-
Abstract:
Pediatric drug accessibility has become a global problem,pediatric drug shortages and off-label uses are very seri?ous. In China,lack of suitable varieties,appropriate dosage forms and specifications,weak foundations on clinical trials,irregular prescribing behavior and irrational drug use and other issues on pediatric drugs are still outstanding. To improve pediatric drug accessi?bility,it may need all aspects work together,that is,cooperation of the national macro-policy support,participation of enterprises and medical institutions,to establish realistic goals and programs to address pediatric drug problem. This paper studies the foreign pediat?ric regulation measures and policies and by comparing foreign policies to China′s current situation,we can find out the problems and defects,give appropriate advice,in order to provide advice and reference to promote the development of pediatric drug.
