摘要
本文对美国非处方药进行研究,发现非处方药具有安全窗宽、无需执业医师指导用药等特点,这些特点决定了非处方药在上市路径、申报资料递交、审评及监管、标签等方面与处方药存在差异。此外,还对美国2020年3月27日实施的非处方药改革进行研究,以期为我国非处方药的申报、审评和监管提供参考。
This paper studied the OTC drugs marketed in the United States and found that OTC drugs have their own characteristics such as wide safety margin and without the supervision of a physician for safe and appropriate use.The abovementioned features determine that OTC drugs are distinguished from prescription drugs in marketing pathway,dossier submission,review and supervise,as well as labeling.In addition,we also looked into the implementation of OTC drug reform in the US on March 27,2020,in order to provide reference for the application,review and supervision of OTC drugs in China.
作者
关宏峰
李艳蓉
杨娜
杨悦
GUAN Hong-feng;LI Yan-rong;YANG Na;YANG Yue(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China;School of Pharmaceutical Sciences,Tsinghua University,Beijing 100084,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;Key Laboratory of Innovative Drug Research and Evaluation,National Medical Products Administration,Beijing 100084,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第2期183-188,共6页
Chinese Journal of New Drugs
关键词
美国
非处方药
上市路径
专论程序改革
标签
审评及监管
the United States
OTC drugs
marketing pathway
monograph procedure reform
labeling
review and supervision
