药品监管工作中劣药的界定及建议  

Definition and Suggestions on Substandard Drugs from Drug Supervision Practice

作　　者：贡勇斌 涂画[2] 江得志 陈相龙 GONG Yongbin;TU Hua;JIANG Dezhi;CHEN Xianglong(Hubei Medical Products Administration,Wuhan,Hubei,China 430071;Hubei Center for Disease Control and Prevention,Wuhan,Hubei,China 430079;HuBei Government Affairs Management Office,Wuhan,Hubei,China 430071)

机构地区：[1]湖北省药品监督管理局,湖北武汉430071 [2]湖北省疾病预防控制中心,湖北武汉430079 [3]湖北省政务管理办公室,湖北武汉430071

出　　处：《中国药业》2020年第2期7-9,共3页China Pharmaceuticals

摘　　要：目的优化监管工作中对劣药的界定方法,为完善法律、改进监管措施提供参考。方法从监管实践案例出发,结合《中华人民共和国药品管理法》和《中华人民共和国刑法》等法律法规,分析劣药的界定,以及监管处理方式和存在的问题。结果与结论劣药的产生有主观故意和非主观故意等之分,现行法律体系中应对劣药的不同情形进行说明,区分对待,需改进假药劣药的简单划分,应采取更灵活的监管手段,进一步修改和完善相关法律法规条款。Objective To optimize the definition of substandard drugs in supervision practice,and to provide references for improvement of relevant laws and regulatory measures. Methods On the basis of regulatory practices and combined with laws and regulations such as the Drug Administration Law and Criminal Law of People’ s Republic of China,the definition of substandard drugs based on the provincial drug classification,as well as the regulatory treatment methods and existing problems were analyzed. Results and Conclusions The production of substandard drugs can be divided into subjective intentions and non-subjective intentions. The current legal system should explain the different situations of substandard drugs and treat them differently. The simple division of substandard drugs needs to be improved. More flexible supervision methods should be adopted to further amend and improve relevant laws and regulations.

关 键 词：药品监管 药品管理法 劣药 界定 建议 

分 类 号：R954[医药卫生—药学]