摘要
目的:为药品检验机构等相关单位落实《药品管理法》,规范高效开展假劣药认定检验提供参考。方法:通过对比研究、文献研究和政策分析,从假劣药定义、认定依据等方面的变化,分析新修订《药品管理法》对假劣药认定检验的影响,以及假劣药认定检验实际工作中面临的问题和挑战,提出落实《药品管理法》做好假劣药认定检验的建议。结果:新修订《药品管理法》对假劣药的重新定义缩减了形式而增加了实际内容,对假劣药认定依据仅原则性规定应当载明检验结论,相关行政责任条款实施中要求判断是否属于假劣药,这都为假劣药认定检验带来了挑战。并且,假劣药认定检验实践中存在机构之间衔接协作制度机制不健全、药品检验机构相关功能定位未明确、受技术能力不足和样品不合规等条件限制、检验结论出具及收费和经费保障要求需进一步明确等问题。结论:建议明确药品检验机构关于假劣药认定检验的定位分工,完善药品检验机构之间的协作及与司法机关的衔接机制,明确假劣药认定检验受理、结论出具和使用、收费及经费保障相关要求。
Objective: To provide references for drug inspection institutions and other relevant units to implement the Drug Administration Law, and to identify and inspect counterfeit and inferior drugs systematically and efficiently. Methods: Through comparative study, literature research and policy analysis, the impact of the newly revised Drug Administration Law on the identification and inspection of counterfeit and inferior drugs was analyzed in the respects of the definitions and identification basis of counterfeit and inferior drugs. After the problems and challenges in the actual work of identification and inspection for counterfeit and inferior drugs was analyzed, suggestions on implementation of the Drug Administration Law and the identification and inspection for counterfeit and inferior drugs were put forward. Results: The newly revised Drug Administration Law redefines the counterfeit and inferior drugs, reduces the forms and adds the actual contents. For example, as for the identification basis of counterfeit and inferior drugs, it stipulates that the inspection conclusion should be stated.The implementation of the relevant administrative liability clause requires the judgment of whether it belongs to counterfeit and inferior drugs. These have brought challenges to the identification and inspection of counterfeit and inferior drugs. In addition, there are some problems in the identification and inspection of counterfeit and inferior drugs. For example, the system and mechanism of convergence and cooperation among institutions are not perfect. The functions and roles of drug inspection institutions are not clear, the technical ability is insufficient,and the samples are not in conformity with the regulations. The requirements for issuing inspection conclusions,charging fees and fund guarantee need to be further clarified. Conclusion: It is suggested to clarify the specific tasks of the drug inspection institutions in identification and inspection of counterfeit and inferior drugs, improve the coordination among drug inspection institutions and the linkage mechanism with judicial authorities, and clarify the relevant requirements for the acceptance of identification for counterfeit and inferior drugs, the issuance and use of the inspection conclusions, the charge and the fund guarantees.
作者
张炜敏
黄清泉
梁静
杨青云
乔涵
黄宝斌
Zhang Weimin;Huang Qingquan;Liang Jing;Yang Qingyun;Qiao Han;Huang Baobin(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药事》
CAS
2021年第7期727-734,共8页
Chinese Pharmaceutical Affairs
基金
国家重点研发计划课题(编号2018YFC0830802)
中国食品药品检定研究院中青年发展研究基金课题(编号2020G1)。
关键词
药品管理法
假药
劣药
假劣药
检验
药品检验机构
Drug Administration Law
counterfeit drugs
inferior drugs
counterfeit and inferior drugs
inspection
drug inspection institutions
