2011-2015年我国药品监管统计年报分析

发布时间：2018-08-26 13:26

【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。
[Abstract]:Objective: to provide reference for drug control department to strengthen drug supervision. Methods: the annual statistics of national drug supervision and control for 5 consecutive years from 2011 to 2015 were collected. The methods of literature analysis, content analysis, comparative analysis and secondary analysis were used to examine and approve the drug production license, business license and advertisement in the statistical annual report. Traditional Chinese medicine variety protection, drug complaints, drug case investigation and other data analysis. Results & conclusion: the number of drug manufacturing and management enterprises in China increased year by year, but the growth rate of manufacturing enterprises was slowing down, while the retail chain stores of licensed enterprises had the tendency of surpassing retail individual drugstores. Compared with the number of approved drug advertisements, the decrease of the number of protected varieties of traditional Chinese medicine is more obvious; the increase of drug complaints does not cause the increase of the number of drug cases, but a downward trend. It is suggested that drug regulatory departments should strictly approve and approve drug production and business licenses, reform the drug advertising regulation and the protection system of traditional Chinese medicine varieties, increase the investigation and handling of drug complaints and cases, and give play to the role of the media and the public in supervising public opinion. Further improve the quality and efficiency of drug supervision in China.
【作者单位】：第四军医大学药学院;
【分类号】：R95

【参考文献】