目的 探讨完善国家药品抽验工作体制的方法，增强国家药品抽验工作效能，提高药品质量风险预警能力。方法 利用三年来国家药品抽验工作的相关数据，对药品质量状况开展趋势性分析，通过对国家药品抽验工作成效的总结，提出相应的对策和建议。结果与结论 加大抽样过程中的检查力度，通过实行多样灵活的抽验形式提高抽验效率，以多形式多渠道的方法强化抽验成果应用，进一步完善药品质量公告发布机制，丰富药品质量公告的形式和内容，增加对抽验数据的解读和分析，以此加强抽验与监管工作有效衔接。
Abstract
OBJECTIVE To improve the method of national drug sampling and testing system, Enhance the work efficiency of national drug sampling and testing, improve early warning ability of drug quality risk. METHODS By using relevant data of national drug sampling and testing in the past 3 years, to analysis the tredency of drug quality situation. Through summarizing the effect of national drug sampling and testing work, put forward suggestions and countermeasures.RESULTS AND CONCLUSION Strengthening efforts on sampling and testing, improving the efficiency by using varied and flexible sampling form, enhancing the application effects of sampling and testing through multi forms and channels, further perfect drug quality announcement releasing mechanism, enriching the form and content of drug quality announcement, increasing the interpretation and analysis of sampling data, in order to enhance the effective cohesion between the sampling and testing work and supervision management.
关键词
国家药品抽验 /
质量分析 /
药品质量 /
安全监管
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Key words
national drug sampling and testing;quality analysis;drug quality /
drug safety regulatory
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中图分类号：
R951
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参考文献
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