2011-2015年我国药品监管统计年报分析  

Analysis of Drug Regulatory Statistical Yearbooks in China during 2011-2015

作　　者：祁永飞 包晗[1] 邱鹏程[1] 张鑫磊[1] 王伟[1] 王玉琨[1] 

机构地区：[1]第四军医大学药学院,西安710032

出　　处：《中国药房》2017年第22期3135-3138,共4页China Pharmacy

摘　　要：目的:为药监部门加强药品监管工作提供参考。方法:收集2011-2015年连续5年国家药品监管统计年报,采用文献分析、内容分析、对比分析、二次分析等方法对统计年报中有关药品生产许可、经营许可、广告审批、中药品种保护、药品投诉、药品案件查处等数据进行分析。结果与结论:我国药品生产企业和经营企业数量逐年增加,但生产企业的增速有放缓趋势,而持证经营企业中零售连锁企业门店有超越零售单体药店的趋势;相比批准的药品广告数量的下降趋势,中药保护品种数量的下降更为明显;药品投诉增加的同时并未引起查处的药品案件数量的增加,反而呈下降趋势。建议药监部门通过严格药品生产经营许可审批、改革药品广告监管和中药品种保护制度、加大药品投诉和案件的查处力度、发挥媒体和群众的舆论监督作用,进一步提升我国药品监管工作的质量和效率。OBJECTIVE：To provide reference for strengthening drug regulation in drug administration department. METHODS：Drug regulatory statistical yearbooks during 2011-2015 were collected. Literature analysis,content analysis,comparative analysis and secondary analysis were conducted to analyze and explore the drug production license,business license,advertising approval,protection of TCM varieties,drug complaints,investigation and punishment of drug cases,etc. in statistical yearbook. RESULTS CONCLUSIONS：The number of drug manufacturers and operating enterprises had been increasing year by year,while the retail chain stores in certified enterprises showed tendency to go beyond the single retail pharmacy. Compared with the down-ward trend of number of approved drug advertisements,the number of protected varieties of TCM decreased more obviously. The increase in number of drug complaints did not cause the number of investigated and punished drug cases at the same time,which showed a downward trend. It is suggested to further improve the quality and efficiency of drug regulatory work in China by strict drug production license approval,reforming drug advertising regulation and TCM varieties protection system,intensifying efforts to investigate and punish drug complaints and cases,and playing the supervision of public opinion role of the media and the masses.

关 键 词：药品监管 统计年报 分析 

分 类 号：R95[医药卫生—药学]