藥品抽檢是中國(guó)以及歐美等發(fā)達(dá)國(guó)家和地區(qū)重要的藥品監(jiān)管手段之一。我國(guó)藥品監(jiān)管部門頒布了一系列政策，建立了藥品質(zhì)量風(fēng)險(xiǎn)排查處置機(jī)制，對(duì)探索性研究中發(fā)現(xiàn)嚴(yán)重藥品質(zhì)量風(fēng)險(xiǎn)進(jìn)行控制，取得了良好的成效。通過(guò)對(duì)國(guó)家藥品抽檢探索性研究概況、藥品質(zhì)量風(fēng)險(xiǎn)排查處置機(jī)制基本情況、政策法規(guī)、發(fā)揮的作用等方面的介紹，對(duì)國(guó)家藥品抽檢藥品質(zhì)量風(fēng)險(xiǎn)排查處置機(jī)制進(jìn)行分析與探討，建議在今后的工作中進(jìn)一步提高探索性研究的科學(xué)性，加強(qiáng)探索性研究方法的轉(zhuǎn)化，提高現(xiàn)場(chǎng)檢查的針對(duì)性，提高該機(jī)制的法律效力。

Drug sampling and testing is one of the important drug regulatory methods in China, Europe, the United States and other developed countries and regions. National Medical Product Administration in China has promulgated a series of policies, established a drug quality risk investigation and disposal mechanism to control the serious drug quality risks found in exploratory research, and achieved good results. This mechanism was analyzed and discussed through the introduction of the national drug sampling and testing exploratory research overview, the basic situation, policies and regulations, and its roles. In the future work, it is suggested to further improve the scientific nature of exploratory research, strengthen the transformation of exploratory research methods, improve the targeting of on-site inspections, and improve the legal effect of the mechanism.

R927.1