基于国家药品抽检的药品标准提高分析

Improvement of Drug Standards Based on National Drug Sampling and Testing

目的加强国家药品抽检,协助药品标准提高。方法根据国家药品抽检的基本情况,分析国家药品抽检探索性研究在协助药品标准提高方面的优势、研究内容、工作程序和成果,并提出建议。结果国家药品抽检对协助药品标准提高在制度、样品、技术等方面具有显著优势,针对药品标准的限度设置、项目设置、检验方法、注册标准差异等方面开展研究;国家药品抽检与药品标准的管理部门间已建立了合作机制,制订了相应的工作程序。国家药品抽检中,2014年至2019年,承检机构通过探索性研究累计提出687个品种的药品标准提高建议,包括1796条信息;2020年提出61个品种的国家标准提高建议,23个品种注册标准提高建议和意见,5个进口品种的进口注册标准提高建议和意见。结论建议国家药品抽检针对亟需提高的质量标准设立专项,加强对先进单位的表彰,及时报告在质量标准研究过程中发现的药品质量风险。

Objective To strengthen the national drug sampling and testing and to assist in the improvement of drug standards.Methods According to the basic situation of national drug sampling and testing,the advantages,research content,working procedures and achievements of the exploratory research on national drug sampling and testing in assisting the improvement of drug standards were analyzed,and suggestions were put forward.Results The national drug sampling and testing had significant advantages in terms of the system,sample and technology in assisting the improvement of drug standards.Research was carried out on the limits setting,items setting,test methods and differences in registration standards of drug standards.A cooperation mechanism had been established between the administrative departments of national drug sampling and testing and drug standards,and corresponding working procedures had been formulated.In the national drug sampling and testing,suggestions on the improvement of drug standards for 687 varieties of drugs were put forward from 2014 to 2019 by the testing institutions through the exploratory research,including 1796 pieces of information.Suggestions on the improvement of national standards for 61 varieties of drugs,suggestions and opinions on the improvement of the registration standards for 23 varieties of drugs and the import registration standards for five imported varieties of drugs were put forward in 2020.Conclusion It is suggested that the national drug sampling and testing should set up special projects for the quality standards that need to be improved,strengthen the recognition of advanced units,and timely report the drug quality risks found in the process of quality standard research.