摘要
本文旨在深入分析美国儿科药物激励政策以及实施成效,为我国儿科药物研发激励政策提供建议。采用文献研究法对美国儿科用药监管法规体系进行回顾,对美国儿科药物研发数据进行统计分析。美国《最佳儿童药品法案》和《儿科研究平等法案》采用“自愿与强制相结合”的策略鼓励企业开展儿科研究,以完善儿科用药信息。其中,《最佳儿童药品法案》是从监管机构角度判断儿科研究必要性,给予奖励,鼓励企业对药物的潜在儿科用途开展研究,以完善药物的儿科用药信息。《儿科研究平等法案》直接强制要求企业对提出新药申请、补充申请的药品或可能大规模用于儿童的已上市成人用药开展儿科研究,以完善儿科用药信息,让成人和儿童在共患疾病中获得平等的治疗机会。建议我国鼓励药物的儿科用途研究,针对成人用药超说明书用于儿童的情况进行调研,增加完善成人用药的儿科用药信息的强制性政策,对潜在儿科用途开展研究的药物给予额外的市场独占期保护。
The aim of this article is to provide recommendations for development policies of pediatric drug in China,based on an in-depth analysis on the incentive policies of pediatric drug and the implementation subsequence in the US.This paper reviews the pediatric drug regulatory system in US and conducts a statistical analysis on the pediatric drug development data in US through literature research.In order to improve pediatric medication information,Best Pharmaceuticals for Children Act and Pediatric Research Equity Act in US adopt the strategy of“combination of voluntary and compulsory”to encourage companies to carry out pediatric studies.Among them,Best Pharmaceuticals for Children Act judges the necessity of pediatric studies from the perspective of regulatory agencies,and encourage companies to carry out studies on the potential pediatric uses of drugs by giving awards,so as to improve the pediatric medication information of drugs.Pediatric Research Equity Act directly requires companies to carry out pediatric studies on drugs,during which application or supplement to an application is proposed for new drugs or adult drugs that may be used for children on large scale,so as to improve pediatric medication information and better guide the use of drugs in children,and make children and adults are able to equally access to treatment in comorbid diseases.It is suggested that China should also encourage studies on pediatric uses of drugs,investigate the off-label use of adult drugs for children,add compulsory policies to improve pediatric medication information for adult drugs,and provide additional market exclusivity protection for drugs that are studied for potential pediatric uses.
作者
龚传欢
杨悦
田丽娟
GONG Chuan-huan;YANG Yue;TIAN Li-juan(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;School of Pharmaceutical Sciences,Tsinghua University,Beijing 100084,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第11期1042-1047,共6页
Chinese Journal of New Drugs
关键词
儿科药物
儿科药物研发
研发激励政策
pediatric drug
pediatric drug development
incentive policies for pediatric drug development
