[关键词]
[摘要]
我国药品上市后质量抽查检验工作是药品监督执法和风险管理的重要技术支撑手段,有效打击了假冒伪劣药品,保护公众用药安全。这项工作的法律依据充分,主要包括国家药品抽检和地方药品抽检,用于评价和监督药品质量。通过药品抽检可以震慑不法分子,警示用药风险,服务产业发展。然而,抽样和检验工作质量尚需进一步加强,地方保护主义时有存在,建议加强新法规的宣贯培训、加强抽检工作管理、加大制售假劣药品的惩戒力度、加强药品质量风险管理并深挖药品抽检“大数据”。
[Key word]
[Abstract]
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.
[中图分类号]
R927.1
[基金项目]