关于国家药品标准提高工作的思考
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摘要
目的为国家药品标准提高工作提供参考。方法通过查阅文献,结合药品标准管理工作实践,分析我国国家药品标准提高过程中存在的问题,并提出相应的管理建议。结果与结论国家药品标准提高工作是药品上市后监管中极端重要的一项工作,对于保障人民群众安全用药发挥了重要作用。建议在国家药品标准提高立项阶段,应该充分调研药品临床应用情况以及标准存在问题,紧密与国家药品评价性抽验等部门互动,建立沟通机制,避免浪费资源,及时将可行建议转化为国家药品标准。此外,应当建立以国家药典委员会为核心的药品标准研究集群,制定鼓励药品生产企业参与国家药品准制修订工作的措施,通过绩效考核等方式提高国家药品标准提高工作完成质量和效率。
OBJECTIVE To provide references for the improvement of national drug standards. METHODS By referring to the literatures and combining with the practice in drug standard management, analyzed the problems existing in the process of improving China's national drug standards, and puts forward corresponding management suggestions. RESULTS & CONCLUSION The improvement of national drug standards is extremely important in drug post-marketing surveillance, and plays an important role in supplying the people drug safely and effectively. In the phase of setting up the projects of improving drug standards, it should fully investigate the drug use in clinical and problems of drug standards, interact with institutions that take change of the national drug sampling and testing for quality evaluation closely, and establish the communication mechanism,avoid the waste of resources, convert feasible suggestions to the national drug standards timely. In addition, establish drug standards research cluster that take the national pharmacopoeia committee as the core, formulate the measures that encourage pharmaceutical producing enterprises to participate in drug standard system revision, and improve the quality and efficiency of national drug standards by means of performance evaluation.
OBJECTIVE To provide references for the improvement of national drug standards. METHODS By referring to the literatures and combining with the practice in drug standard management, analyzed the problems existing in the process of improving China's national drug standards, and puts forward corresponding management suggestions. RESULTS & CONCLUSION The improvement of national drug standards is extremely important in drug post-marketing surveillance, and plays an important role in supplying the people drug safely and effectively. In the phase of setting up the projects of improving drug standards, it should fully investigate the drug use in clinical and problems of drug standards, interact with institutions that take change of the national drug sampling and testing for quality evaluation closely, and establish the communication mechanism,avoid the waste of resources, convert feasible suggestions to the national drug standards timely. In addition, establish drug standards research cluster that take the national pharmacopoeia committee as the core, formulate the measures that encourage pharmaceutical producing enterprises to participate in drug standard system revision, and improve the quality and efficiency of national drug standards by means of performance evaluation.
引文
[1]GAO T B,CONG J.Present condition and strategies of post market drug surveillance in china[J].Chin J Pharm Affa(中国药事),2007,21(11):869-870.
[2]国务院关于印发国家食品药品安全“十一五”规划的通知[EB/OL].[2007-04-07].http://www.gov.cn/zwgk/2007-06/05/content_637391.htm.
[3]国务院关于印发国家药品安全“十二五”规划的通知[EB/OL].[2012-01-20].http://www.gov.cn/gongbao/content/2012/content_2068275.htm.
[4]国务院关于印发“十三五”国家药品安全规划的通知[EB/OL].[2017-02-14].http://www.gov.cn/zhengce/content/2017-02/21/content_5169755.htm.
[5]聂黎行,张毅,戴忠,等.国家药品评价抽验对中药标准提高的促进作用[J].中国药业,2013,22(22):2-3.
[6]ZHU J L,YANG X,LI Z Y.Development and prospect on the marketed drug sampling and testing for quality evaluation[J].Chin J New Drug(中国新药),2015,24(16):1810-1815.
[7]YU J Y,YU B Y,QIAN Z Z.Disscuion about improvement of national drug standards[J].Chin J Pharm Affa(中国药事),2011,25(10):955-958.
[8]YU J Y,YU B Y,QIAN Z Z.Discussion on the establishment of evaluation mechanism of national drug standards[J].Chin JPharm Affa(中国药事),2010,9(24):854-856.
[2]国务院关于印发国家食品药品安全“十一五”规划的通知[EB/OL].[2007-04-07].http://www.gov.cn/zwgk/2007-06/05/content_637391.htm.
[3]国务院关于印发国家药品安全“十二五”规划的通知[EB/OL].[2012-01-20].http://www.gov.cn/gongbao/content/2012/content_2068275.htm.
[4]国务院关于印发“十三五”国家药品安全规划的通知[EB/OL].[2017-02-14].http://www.gov.cn/zhengce/content/2017-02/21/content_5169755.htm.
[5]聂黎行,张毅,戴忠,等.国家药品评价抽验对中药标准提高的促进作用[J].中国药业,2013,22(22):2-3.
[6]ZHU J L,YANG X,LI Z Y.Development and prospect on the marketed drug sampling and testing for quality evaluation[J].Chin J New Drug(中国新药),2015,24(16):1810-1815.
[7]YU J Y,YU B Y,QIAN Z Z.Disscuion about improvement of national drug standards[J].Chin J Pharm Affa(中国药事),2011,25(10):955-958.
[8]YU J Y,YU B Y,QIAN Z Z.Discussion on the establishment of evaluation mechanism of national drug standards[J].Chin JPharm Affa(中国药事),2010,9(24):854-856.