中国药品上市后抽验模式现状及问题

孙苓苓; 毕开顺<sup>*</sup>

引用本文:	孙苓苓,毕开顺.中国药品上市后抽验模式现状及问题[J].中国现代应用药学,2012,29(8):762-765.
	SUN Lingling,BI Kaishun.Current Situation and Problems of Chinese Sampling Test Mode for Drugs Launched on the Market[J].Chin J Mod Appl Pharm(中国现代应用药学),2012,29(8):762-765.

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中国药品上市后抽验模式现状及问题
孙苓苓^1,2, 毕开顺¹
1.沈阳药科大学，沈阳 110016;2.辽宁省食品药品检验所，沈阳 110023

摘要:

目的在综合分析中国药品上市后抽验模式现状及问题的基础上，提出药品上市后抽验的建议。方法通过文献研究的方法，发现中国药品上市后抽验模式中存在的问题，并提出相关建议。结果与结论在药品抽验中引入以风险为基础的抽验模式，将药品上市后抽验结果与药品监管相衔接。

关键词: 药品抽验模式评价抽验监督抽验

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Current Situation and Problems of Chinese Sampling Test Mode for Drugs Launched on the Market

SUN Lingling^1,2, BI Kaishun¹

1.Shenyang Pharmaceutical University, Shenyang 110016, China;2.Liaoning Institute of Food and Drug Control, Shenyang 110023, China

Abstract:

OBJECTIVE Through comprehensively analyzing the current situation and problems existing in the sampling test mode for drugs launched on the market, to put forwards some recommendations of pharmaceuticals market. METHODS Through literature research, found the defect of drug testing mode in abroad and made suggestions. RESULTS AND CONCLUSION We should introduce the risk-based testing mode to the drug sampling test, and put the results of drug sampling test and drug supervision together.

Key words: sampling test evaluation sampling test supervision sampling test