我國(guó)藥品上市后質(zhì)量抽查檢驗(yàn)工作是藥品監(jiān)督執(zhí)法和風(fēng)險(xiǎn)管理的重要技術(shù)支撐手段，有效打擊了假冒偽劣藥品，保護(hù)公眾用藥安全。這項(xiàng)工作的法律依據(jù)充分，主要包括國(guó)家藥品抽檢和地方藥品抽檢，用于評(píng)價(jià)和監(jiān)督藥品質(zhì)量。通過(guò)藥品抽檢可以震懾不法分子，警示用藥風(fēng)險(xiǎn)，服務(wù)產(chǎn)業(yè)發(fā)展。然而，抽樣和檢驗(yàn)工作質(zhì)量尚需進(jìn)一步加強(qiáng)，地方保護(hù)主義時(shí)有存在，建議加強(qiáng)新法規(guī)的宣貫培訓(xùn)、加強(qiáng)抽檢工作管理、加大制售假劣藥品的懲戒力度、加強(qiáng)藥品質(zhì)量風(fēng)險(xiǎn)管理并深挖藥品抽檢“大數(shù)據(jù)”。

The post-marketing drugs sampling and testing work in China has been an important technical support method for drug supervision and risk management, which effectively fought the counterfeit and inferior drugs, and protected the public from drug quality hazards. It was fully based on the laws and regulations, mainly includes national and local types, which was used to evaluate and supervise the quality of drugs. It can deter criminals, warn drug risks, and serve industry development. However, the work quality needs to be further improved, and local protectionism still exists. It is suggested to strengthen the publicity and training of new laws and regulations, strengthen work management, increase punishment for the manufacture and sale of counterfeit and inferior drugs, strengthen drug quality risk management, and dig deeper into the "big data" of drug sampling and testing.

R927.1