新要求下的假劣药检验工作模式研究

Study on the pattern of falsified and substandard drug testing based on the new legal requirements

分析新修订的《药品管理法》和《关于办理危害药品安全刑事案件适用法律若干问题的解释》,梳理假劣药定义的新变化与认定的新要求,探讨新形势下的假劣药认定工作模式。新形势下的假劣药认定分为依法需要和不需要检验2种情形:对于依法需要进行检验的,需要从谁来检、能否检、如何出具检验结果3个方面来考虑;对于需要检验支撑的假劣药认定,分别对2006年“齐二药亮菌甲素注射液事件”和2015年违法生产销售银杏叶提取物及制剂案件进行分析。新的假劣药认定工作模式提高了认定工作效率,合理使用检验资源,打破传统的检验与认定捆绑的思维模式。为落实新的工作模式,地市级以上药品监管部门需依法明确是否需要检验支撑的认定情形,国家级与省级药品检验机构要建立与监管职能相匹配的分工协作机制,药品检验机构需要明确开展假劣药检验的样品、检验依据和检验结论的要求。

Based on the new changes in the definition of falsified and substandard drugs and the new requirements for their identification in newly revised"Drug Administration Law"and"Interpretation for Handling the Criminal Cases Endangering Drug Safety",this paper discusses a new working mode for the detection of falsified and substandard drugs.In the new working model,the detection of falsified and substandard drugs can be classified into two kinds:to need and not to need the support of testing results.If testing is needed,three factors should be considered,i.e.,the implementer of testing,testing capability,and presentation of testing result.The paper cited two typical examples taking place respectively in 2006 and 2015 to elaborate how testing result supported the detection of falsified and substandard drugs,one is about illegally adding diglycol in injection,another is about adulterated Ginkgo biloba leaves and their extracts.In order to improve the quality and efficiency of the detection of falsified and substandard drugs and optimize the utilization of drug testing resources,the testing of falsified and substandard drugs under the new requirements should be based on the needs of the identification,with the goal of supporting the drug regulatory department to issue the identification opinion about the falsified and substandard drugs.The model will change the traditional understanding on the role of drug testing results in supporting the confirmation of falsified and substandard drugs,to delink the connection between detection and testing,making the testing result not the precondition for the confirmation of falsified and substandard drugs.In order to implement the new work mode,drug regulatory authorities at prefecture level and above need to clarify the identification of whether inspection support is needed according to the laws,national and provincial drug inspection institutions need to establish a division of labor and cooperation mechanism that matches the regulatory functions,and drug testing institutions need to clarify the requirements for samples,standards for testing,and testing conclusion.