| 关于完善我国非处方药上市路径管理的建议 |
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| 引用本文： | 杨建红,陶巧凤,汪鳌,贾颖君,孟晓峰,叶真,李丽华,王冬妮,张彦彦,陈江鹏,黎泽琳,陈震.关于完善我国非处方药上市路径管理的建议[J].中国药事,2020,34(11):1269-1274. |
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| 作者姓名： | 杨建红 陶巧凤 汪鳌 贾颖君 孟晓峰 叶真 李丽华 王冬妮 张彦彦 陈江鹏 黎泽琳 陈震 |
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| 作者单位： | 沈阳药科大学亦弘商学院,北京 100055;浙江省食品药品检验研究院,杭州 310052;中国非处方药物协会,北京 100098;上海强生制药有限公司,上海 200233;人福普克药业(武汉)有限公司,武汉 430206;北京金象大药房医药连锁有限责任公司,北京 100035;百洋医药集团有限公司,北京 100006;拜耳医药保健有限公司,北京 100020;沈阳药科大学工商管理学院,沈阳 110016;沈阳药科大学亦弘商学院,北京 100055 ；郑州大学药学院,郑州 450001 |
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| 摘 要： | 目的：为完善我国非处方药上市路径管理提供参考。方法：基于对国内外非处方药上市路径管理的对比研究结果，结合问卷调研结果进行综合分析。结果与结论：从药品全生命周期管理的角度，提出了完善我国非处方药上市路径管理的建议，包括建立单独的非处方药注册审评审批程序、完善非处方药转换管理制度、探索我国非处方药专论制度等。
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| 关 键 词： | 非处方药 上市路径 药品注册 药品分类转换 非处方药专论 |
Suggestions on Improving China's OTC Market Path System |
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| Yang Jianhong,Tao Qiaofeng,Wang Ao,Jia Yingjun,Meng Xiaofeng,Ye Zhen,Li Lihu,Wang Dongni,Zhang Yanyan,Chen Jiangpeng,Li Zelin,Chen Zhen.Suggestions on Improving China's OTC Market Path System[J].Chinese Pharmaceutical Affairs,2020,34(11):1269-1274. |
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| Authors: | Yang Jianhong Tao Qiaofeng Wang Ao Jia Yingjun Meng Xiaofeng Ye Zhen Li Lihu Wang Dongni Zhang Yanyan Chen Jiangpeng Li Zelin Chen Zhen |
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| Abstract: | Objective: To provide a reference for improving the management of marketing paths for OTC drugs in China. Methods: Based on the results of comparative study on the management of OTC drug marketing paths at home and abroad, combined with the results of questionnaire surveys, a comprehensive analysis was conducted. Results and Conclusion: From the perspective of drug life cycle management, suggestions for improving the management of marketing paths for OTC drugs in China are put forward in this article, such as establishing a separated OTC drug registration review and approval procedure, improving the management of Rx-to-OTC switch, and exploring the OTC drug monograph system in China and so on. |
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