国家药品抽检中补充检验方法和检验项目的应用现状与思考

Current situation and review on application of supplementary testing methods and items in national drug sampling and testing

2013年以来国家药品监管部门批准了91个品种的78个补充检验方法和检验项目,2014—2019年国家药品抽检中通过补充检验方法和检验项目检出13个品种83批次的掺杂掺假药品,占检验批次4.7%,对打击掺杂掺假药品和行为,保护公众用药安全发挥了重要作用。今后的工作中,建议相关单位正确理解单独出具补充检验报告书的要求和补充检验方法和检验项目的溯及既往的属性,并且充分利用探索性研究和跟踪抽检等手段扩大抽检成果,加大处罚力度,严厉打击药品掺杂掺假。

The national drug regulatory authority has approved 78 supplementary testing methods and items for 91 drugs since 2013.In the national drug sampling and testing during 2014 to 2019, 83 batches counterfeit drugs of 13 varieties were detected through the approved supplementary testing methods and items, with the detection rate of 4.7%, which played an important role in counterfeit drugs and protecting public safety.In the future work, it is suggested that relevant units correctly understand the requirements for the supplementary testing report and the traceability of supplementary testing methods and items, make full use of exploratory research and follow-up sampling and testing to expand the results,and reinforce the punishment to crack down on counterfeit drugs.