| 孙艳艳,陈咏梅,解雪峰,吕雄文,许伏新.2014至2016年安徽省药品注册现状分析[J].中国药事,2017,(11):1237-1242 |
| 2014至2016年安徽省药品注册现状分析 |
| Analysis of Current Status of Drug Registration in Anhui Province from 2014 to 2016 |
| 投稿时间：2017-06-20 |
| DOI：10.16153/j.1002-7777.2017.11.003 |
| 中文关键词: 药品注册 新药 仿制药 药品再注册 补充申请 现状分析 审批 |
| 英文关键词: drug registration new drug generic drug license renew application supplementary application analysis of status approval |
| 基金项目:国家自然科学基金项目（编号71503006） |
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| 中文摘要: |
| 目的：总结安徽省2014至2016年药品注册情况，为本省的药品研发、申报、审批提供参考。方法：通过梳理药品企业在2014至2106年新药、仿制药、补充申请和再注册申请的情况，对安徽省药品注册申请进行统计分析与评价。结果：近3年，安徽省药品注册申请数量主要集中在药品再注册和补充申请。新药申请中，97%的药品申报临床试验，化学药品占新药申请的90%。仿制药申报品种均为化学药品。结论：安徽省药品注册申报类别分布合理，在生物制品的新药研发上取得进步，中药研发方面有待加强。 |
| 英文摘要: |
| Objective: To summarize the status of drug registration in Anhui Province from 2014 to 2016 and to provide references for the drug research and development, drug registration and approval. Methods: The drug registration applications in Anhui Province from 2014 to 2016 were statistically analyzed and evaluated through teasing out the situation of new drug applications, generic drug applications, supplementary applications and reregistration. Results: The drug registration application mainly consisted of re-registration and supplementary applications in Anhui Province in the past three years. The clinical trial applications accounted for 97% of the new drug applications, chemical drugs accounted for 90% of new drug applications. All the varieties of generic drug applications were chemical drugs. Conclusion: The distribution of drug registration categories in Anhui Province is reasonable, and much progress has been made in the research and development of biological products, yet the research and development of traditional Chinese medicine needs to be enhanced. |
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