国家药品抽检中药品标准的适用性研究
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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.
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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[27]GAO Z F,LIN L.Research on the validity of standards in drug inspection[J].Chin J New Drugs(中国新药杂志),2017,26(3):261-263.
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[29]GAO Z F,ZHANG Q M,YANG H X.Describe the management of pharmaceutical standards in NIFDC[J].Chin Pharm Aff(中国药事),2012,26(8):873-874.
[2]GAO Z F,LIN L.Integrated management mode of post-marketing quality evaluation of drugs[J].Chin J New Drugs(中国新药杂志),2017,26(1):29-31.
[3]ZHU J L,YANG X,LI Z Y,et al.Development and prospect on the marketed drug sampling and testing for quality evaluation[J].Chin J New Drugs(中国新药杂志),2015,24(16):1810-1815.
[4]National Institutes for Food and Drug Control.Annual report on National Drug Sampling and Testing in 2016[EB/OL].[2017-10-09](2018-07-03).http://www.nifdc.org.cn/CL0882/9872.html.
[5]CHEN J,LI Z H,LI Y R,et al.Understanding of correct usage and implement of drug standards in drug analysis[J].Drug Stand China(中国药品标准),2009,10(4):253-255.
[6]YAN J.Problems and solutions in the management of nation drug standards[J].J Shenyang Pharm Univ(沈阳药科大学学报),2015,32(8):651-653.
[7]LIN Q.Analysis on effective management and verification of drug standards in institute for food and drug control[J].Drug Stand China(中国药品标准),2012,13(2):91-92.
[8]ZHOU Z Q,YIN L J,WANG N L.How to find the standard of drug quality according to the standard number[J].China Pharm(中国药业),2015,24(4):3-4.
[9]China Food and Drug Administration.Notice on issuing regulations for the check and inspection of drug quality[EB/OL].[2006-07-21](2018-07-03).http://samr.cfda.gov.cn/WS01/CL0844/10583.html.
[10]China Food and Drug Administration.Provisions for drug registration[EB/OL].[2007-07-10](2018-07-03).http://samr.cfda.gov.cn/WS01/CL0053/24529.html.
[11]JIANG X P.Strategies for developing Chinese drug standards from the Chinese Pharmacopoeia 2010 edition[J].Chin Pharm J(中国药学杂志),2010,45(17):1281-1283.
[12]ZHANG W,LAN F,HONG X X.Overview on the Chinese Pharmacopoeia 2015 edition[J].Chin Pharm J(中国药学杂志),2010,45(17):1743-1746.
[13]ZHANG W.Study on drug standards and drug quality[J].Drug Stand China(中国药品标准),2016,17(1):3-9.
[14]GAO Z F,YANG H X.Study on electronic management for drug inspection standards[J].China Pharm(中国药师),2014,17(4):665-666.
[15]HUANG B B,YANG Q Y,XU M Z,et al.Review on management of supplementary testing method and items and recommendations for future development[J].Chin Pharm Aff(中国药事),2014,28(5):453-456.
[16]JIA C,LI J H,ZHU L.Investigation and analysis of implementation standards in the 471 batch of drug instructions[J].China Pharm(中国药师),2010,13(10):1508-1510.
[17]LU J H.Investigation and analysis on the implementation of standard instructions in 1 066 drug package inserts[J].Chin J Rational Drug Use(中国合理用药探索),2017,14(1):38-41.
[18]CAI H,DU S M.Status of drug execution standards in 84 traditional Chinese medicine injections[J].Her Med(医药导报),2014,33(1):125-127.
[19]Chinese Pharmacopoeia Commission.Interpretation of issues related to the implementation of the Chinese Pharmacopoeia 2015edition[EB/OL].[2015-12-03](2018-07-03).http://www.chp.org.cn/view/ff808081527bfe270154083b2e6952cf?a=GZWJ.
[20]Chinese Pharmacopoeia Commission.Introduction of National Drug Standards.[EB/OL].[2015-07-29](2018-07-03).http://www.chp.org.cn/view/ff8080814 ed3 fb6 e014 ed87 a0 c070360?a=YDXTS.
[21]China Food and Drug Administration.Announcement on the implementation of the Chinese Pharmacopoeia 2015 edition.[EB/OL].[2015-07-15](2018-07-03).http://samr.cfda.gov.cn/WS01/CL0087/124440.html.
[22]Chinese Pharmacopoeia Commission.Notice on issuing corrigendum of the Chinese Pharmacopoeia 2015 edition.[EB/OL].[2015-12-03](2018-07-03).http://www.chp.org.cn/view/ff80808151622d9f01516706766304f3?a=f2.
[23]Chinese Pharmacopoeia Commission.Notice on issuing corrigendum of the Chinese Pharmacopoeia 2015 edition(the second times).[EB/OL].[2016-02-22](2018-07-03).http://www.chp.org.cn/view/ff808081527bfe27015306e2fc961ec9?a=f2.
[24]Chinese Pharmacopoeia Commission.Notice on issuing corrigendum of the Chinese Pharmacopoeia 2015 edition(the third times).[EB/OL].[2016-08-23](2018-07-03).http://www.chp.org.cn/view/ff808081559d1ea30156b30e8bf734b4?a=KWHXYP.
[25]TIAN J,ZHANG Z F.Main problems and analysis of modification of registration specifications in the supplementary application[J].Chin J New Drugs(中国新药杂志),2014,23(10):1118-1120.
[26]GAO Z F,LIN L,YANG H X.Research on the theoretical basis to the drug emergency inspection management[J].Chin J Pharmacovigilance(中国药物警戒),2014,11(4):216-218.
[27]GAO Z F,LIN L.Research on the validity of standards in drug inspection[J].Chin J New Drugs(中国新药杂志),2017,26(3):261-263.
[28]GAO Z F,ZHANG Q M.Describe the thought and practice of drug standards management[J].China Pharm(中国药师),2012,15(10):1515-1515.
[29]GAO Z F,ZHANG Q M,YANG H X.Describe the management of pharmaceutical standards in NIFDC[J].Chin Pharm Aff(中国药事),2012,26(8):873-874.