| 胡慧敏,郭冬梅.我国药品注册中商品名使用的监管现状分析[J].中国药事,2021,35(8):862-870 |
| 我国药品注册中商品名使用的监管现状分析 |
| Analysis on the Supervision of Trade Names in Drug Registration in China |
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| DOI：10.16153/j.1002-7777.2021.08.003 |
| 中文关键词: 药品商品名 注册审批 用药安全 药品监管 |
| 英文关键词: drug trade name registration approval medication safety drug administration |
| 基金项目: |
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| 中文摘要: |
| 目的：分析2006年《国家食品药品监督管理局关于进一步规范药品名称管理的通知》出台前后我国国产和进口药品注册中商品名称使用的监管情况。方法：对国家药品监督管理局网站中国产药品商品名及进口药品商品名数据库进行检索，在对数据资料整理筛选的基础上进行统计分析。结果：药品商品名的批准数量有所减少，其中化学药品占主要地位，生物制品数量总体增长；剂型上注射剂占比最大； 规格上基本实现了同一生产企业同一药品使用同商品名的要求。结论：药品商品名的规范有利于解决 “一药多名”产生的药价虚高以及用药安全问题，提高药品的注册审批效率，鼓励药品研发创新和知识产权保护，但商品名的审批尚存在部分问题，需进一步完善商品名的注册审批体系。 |
| 英文摘要: |
| Objective: To analyze the supervision of trade name use in the registration of domestic and imported drugs in China during the prmulgation of the Notice of National Food and Medical Products Administration on Further Standardizing Drug Name Management in 2006. Methods: The database of Chinese and imported drug trade names on the website of National Medical Products Administration was searched and statistically analyzed on the basis of sorting and screening the data. Results: The number of approved drug trade names decreased, in which chemical drugs accounted for the main position, and the number of biological products increased overall. In terms of the dosage form, injection accounted for the largest proportion. Specifications basically meet the requirements of using the same trade name with the same drug produced by the same manufacturer. Conclusion: The standardization of drug trade names is helpful to solve the problem of high drug price and drug safety caused by "one drug with more than one name", improve the efficiency of drug registration and approval, and encourage drug R & D innovation and intellectual property protection, but there are still some problems in the examination and approval of trade names and the registration and approval system of trade names which need to be further improved. |
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