药品进口备案现状与存在问题的分析  

Analysis of the Current Situation and Existing Problems of Drug Import Filing

作　　者：李立婕 陈继建 高庆权 漆亚乔 Li Lijie;Chen Jijian;Gao Qingquan;Qi Yaqiao(Guangzhou Institute for Drug Control,Guangzhou 510160,China;Guangzhou Market Supervision and Administration Bureau,Guangzhou 510620,China;Guangzhou Food and Drug Evaluation Center,Guangzhou 510440,China;Guangzhou Institute for Food Inspection,Guangzhou 511406,China)

机构地区：[1]广州市药品检验所,广州510160 [2]广州市市场监督管理局,广州510620 [3]广州市食品药品审评中心,广州510440 [4]广州市食品检验所,广州511406

出　　处：《中国药事》2024年第12期1357-1362,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:总结、分析药品进口备案工作现状,探索我国现行药品进口备案制度微调趋势,为今后政策制定和优化革新提供参考。方法:运用文献查询、数据统计和综合分析的方法,梳理药品进口备案中存在的问题,找出各类问题的主要成因及其管理现状。研究近年来我国关于药品进口备案相关文件公告的政策趋势。结果:针对存在问题提出解决方法,施行新方法后药品进口备案现状有效改善。结论:提高对药品进口备案相关法规和政策文件的认识,将其合理运用在实际工作中。建议依国际发展趋势弹性调整药品进口备案执行层面的审查规则,以保证企业合规申报,同时提高进口药品通关效率。Objective:To summarize and analyze the current situation of drug import filing work,explore the trend of fine-tuning the current drug import filing system in China,and provide reference for future policy formulation and optimization reform.Methods:By using literature review,data statistics,and comprehensive analysis methods,the problems existing in drug import filing were sorted out,and the main causes management status of various problems were found out.The policy trend in recent years regarding the announcement of relevant documents for drug import filing in China was studied.Results:Solutions were proposed for the existing problems,and the implementation of the new method effectively improved the current situation of drug import filing.Conclusion:This study helps to enhance understanding of the relevant laws and policies on drug import registration,and facilitates their rational application in practical work.It is suggested to flexibly adjust the review rules for the implementation of drug import filing in accordance with international development trends,in order to ensure compliance declaration by enterprises and improve the efficiency of imported drug clearance.

关 键 词：进口备案 管理现状 合规申报 通关效率 政策 

分 类 号：R95[医药卫生—药学]