中国药房2017，Vol.28Issue(13)：1740-1743,4.DOI:10.6039/j.issn.1001-0408.2017.13.04
美国儿童用药立法保障评析及对我国的启示
Analysis of the Legislation on Pediatric Drug Use in US and Its Enlightenment to China
摘要
Abstract
OBJECTIVE:To provide reference for promoting the development of related legislation work on ensuring pediatric drug use in China. METHODS:The legislation process of pediatric drug use in US,the effects of current Best Pharmaceuticals for Children Act and Pediatric Research Equity Act on pediatric drug use in US were intrduced and analyzed,suggestions on guarantee-ing the accessibility and safety on pediatric drug use in China were put forward. RESULTS & CONCLUSIONS:The policy"6-month period of pediatric exclusive protection"in Best Pharmaceuticals for Children Act has motivated the enthusiasm of phar-maceutical companies developing pediatric studies,while it affects the marketing of generic drugs. Pediatric Research Equity Act has achieved remarkable effect in terms of ensuring the safety of pediatric drug use by forcing pharmaceutical companies to carry out pediatrics assessments,while there is no enough force for the marketed drugs that has not been widely used for children. En-couragement and enforcement are useful methods for promoting development of pediatric drug use. It is suggested to take measures like modifing"one drug two forms"in Prescription Management Regulations,accelerating approvals of related pediatric drugs on the premise that safety is guaranteed,implementing tax preference for related pharmaceutical companies that produced pediatric drugs,promoting the entry of drug reimbursement list and empowering CFDA to force pharmaceutical companies to implement pedi-atric studies to promote the accessibility and safety of pediatric drugs.关键词
最佳儿童药品法/儿科研究公平法/儿童用药/立法Key words
Best Pharmaceuticals for Children Act/Pediatric Research Equity Act/Pediatric drug use/Legislation分类
医药卫生引用本文复制引用
闵晓青,田侃,喻小勇,李浩..美国儿童用药立法保障评析及对我国的启示[J].中国药房,2017,28(13):1740-1743,4.基金项目
教育部哲学社会科学研究重大课题攻关项目(No.14JZD025) （No.14JZD025）
