摘要
目的为解决国家药品抽检中标准的使用问题提供参考,讨论建立标准适用性的实施方案。方法通过梳理药品标准的批复过程与使用流程,分析标准的批准形式、审定部门、修订及编号方式,研究标准适用性的构成因素与影响因素。结果与结论国家药品抽检是上市后监管的重要手段,检验标准的正确与准确对其影响很大。笔者将研究重点定位在标准使用的正确性、准确性和有序性等3方面,建立了标准适用性实施方案并提出多部门协同等针对性措施,可以解决抽检中标准的使用难题。
OBJECTIVE To provide a reference to the use of quality standards in national drug sampling and testing,and establish the implementation plan. METHODS By carding the approval process and usage flow of drug standards,analyzing approval form,authorized department,revise and numbering methods of the standard,composition and influencing factors of standard serviceability were studied. RESULTS AND CONCLUSION The correctness and accuracy of the quality standards have a tremendous impact on national drug sampling and testing which is a significant measure of post-marketing surveillance. The article focuses on three aspects including the correctness,accuracy and orderliness,and then some solutions are proposed such as establishing the implementation plan and multi sector coordination,which can solve the problem of using standards in national drug sampling and testing.
引文
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