| 赵岩松,洪兰,叶桦.加快我国儿童用药研发的政策与法规分析[J].中国药事,2017,(1):1-6 |
| 加快我国儿童用药研发的政策与法规分析 |
| Analysis of the Policy and Regulation on Accelerating the Research and Development of Paediatric Drugs in China |
| 投稿时间：2016-09-13 |
| DOI：10.16153/j.1002-7777.2017.01.001 |
| 中文关键词: 儿童用药 政策法规 药品研发 新药监测期 药品说明书 |
| 英文关键词: paediatric drugs policy and regulation research and development of drugs monitoring period of new drugs drug package insert |
| 基金项目: |
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| 摘要点击次数: 992 |
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| 中文摘要: |
| 目的：为完善儿童用药研发的激励制度提出相应建议。方法：收集我国近几年关于儿童用药研发的相关政策、法规和规章进行梳理和研究。结果与结论：国家应当进一步完善保障儿童用药的法律法规；建立设置儿童用药审评审批的专门程序；设立国家层面的临床试验伦理委员会；适当延长儿科新药的新药监测期；颁布更多的儿童用药相关技术指导原则；给予儿科新药研制更多的财政支持；鼓励药品生产企业主动修订药品说明书。 |
| 英文摘要: |
| Objective: To put forward corresponding suggestions to improve the incentive policy for the research and development of paediatric drugs. Methods: The policies, regulations and guidelines in China concerning the paediatric drugs released in recent years were sorted out and explored. Results and conclusion: The authorities should further build up the law and regulation concerning the research and development of paediatric drugs including setting up the special review and approval procedure for paediatric drugs, establishing the national ethics committee for clinical trials in paediatric population, extending the monitoring period of new drugs for paediatric drugs, publishing more guidelines for the development of paediatric drugs, offering financial preference policy for paediatric drugs, and encouraging the pharmaceutical enterprises to proactively revise the drug package insert. |
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