我国省级药品监管部门药品质量公告发布调查  

Survey on the Announcement of Drug Quality Issued by Provincial Departments of Drug Administration in China

作　　者：贡庆[1] 叶桦[1] 洪兰[1] 

机构地区：[1]复旦大学药学院,上海201203

出　　处：《中国药事》2014年第11期1182-1186,共5页Chinese Pharmaceutical Affairs

摘　　要：目的调查近3年来我国各省级药品监督管理部门药品质量公告发布现状,分析存在的问题,为完善药品质量公告制度设计提供参考。方法检索各地药品质量公告发布途径、发布数量与发布时间、质量公告的内容与形式等,进行回顾性分析。结果质量公告的发布存在途径单一、时效性弱、公告内容难以体现质量责任等问题。结论应从完善相关法律制度、明确药品质量公告发布规范、鼓励开拓发布途径、对药品质量公告内容设立例外情形等方面,来完善药品质量公告发布工作。Objective To provide references for the improvement of the announcement of drug quality through the investigation on the announcements of drug quality issued by provincial departments of drug administration in China in the past three years,as well as analysis of the existing problems.Methods The medium,the number,the content and the form of the announcement of drug quality in various regions were searched and retrospectively analyzed.Results There were some common and serious problems in the announcements of drug quality,for example,the announcement ways were too limited,the timeliness was not so good and the drug quality responsibility couldn＇t be identified from the announcement.Conclusion Some measures should be taken,such as improving the construction of the laws and the regulations concerned,formulating the specification and procedure of the announcement,using more effective announcement ways,and setting the announcement exceptions.

关 键 词：药品监督管理 药品质量公告 发布途径 时效性 制度设计 

分 类 号：R95[医药卫生—药学]