[关键词]
[摘要]
药品抽检是中国以及欧美等发达国家和地区重要的药品监管手段之一。我国药品监管部门颁布了一系列政策,建立了药品质量风险排查处置机制,对探索性研究中发现严重药品质量风险进行控制,取得了良好的成效。通过对国家药品抽检探索性研究概况、药品质量风险排查处置机制基本情况、政策法规、发挥的作用等方面的介绍,对国家药品抽检药品质量风险排查处置机制进行分析与探讨,建议在今后的工作中进一步提高探索性研究的科学性,加强探索性研究方法的转化,提高现场检查的针对性,提高该机制的法律效力。
[Key word]
[Abstract]
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.
[中图分类号]
R927.1
[基金项目]