我国遴选与转换中成药非处方药概况及思考

Selection and Switch-to-OTC of Chinese Patent Medicines in China

目的通过对我国遴选与转换非处方药中成药部分进行回顾,为新形势下中成药非处方药转换评价提供参考。方法梳理我国处方药和非处方药分类管理相关法规及指导原则,回顾中成药非处方药遴选及转换工作,统计我国中成药非处方品种、通过转换评价品种和转出非处方药目录品种。结果国家药品监督管理局公布的我国遴选与转换非处方药目录中,以药品通用名计,中成药共计3900余个,包括1999~2004年通过遴选的中成药3406个,2004~2019年通过转换评价的中成药535个。另外,有25个中成药从非处方药转换为处方药管理。结论中成药非处方药转换评价中,药品上市许可持有人应按照法规及指导原则要求准备资料;转换为非处方药后,药品上市许可持有人应切实做好安全监测,建立有效的药品不良反应收集途径,加强药品不良反应数据分析评价,重视说明书中安全性内容的完善,切实承担起保障患者安全用药的主体责任。

Objective To review some of the Chinese patent medicines that have been selected or switched to overthe-counter(OTC)products in China so as to provide reference for the switch of prescription drugs to OTC(Rx-to-OTC)drugs in China.Methods Regulations on classification management of prescription and nonprescription drugs and the history of Rx-to-OTC switch were reviewed.Chinese patent medicines which were selected as and switched to OTC drugs were analyzed separately.Results On the basis of the list of generic drugs,t here were more than 3900 OTC Chinese patent medicines,including 3406 medicines that had been selected as OTC drugs between 1999 and 2004,535 ones that had been switched to OTC,and 25 OTC Chinese patent medicines switched to prescription drugs in the same period.Conclusion The application materials should meet the requirements of regulations on Rxto-OTC switch applications,After switch to OTC drugs,marketing authorization holders(MAHs)should ensure the safety of these drugs,find effective ways to collect adverse reaction(ADR)reports that should be analyzed to improve the safety instructions of the OTC label.MAHs should be responsible for drug safety for the sake of patients.