药品进口报验资料问题分析与改进建议  

Problems Analysis and Improvement Suggestions of Drug Import Inspection Application Materials

作　　者：梁谋[1] 李强[1] 李东岩[1] LIANG Mou;LI Qiang;LI Dongyan(Beijing Institute for Drug Control·NMPA Key Laboratory of Research and Evaluation of Generic Drugs,State Drug Administration·Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing,China 102206)

机构地区：[1]北京市药品检验所·国家药品监督管理局仿制药研究与评价重点实验室·北京市中药成分分析与生物评价重点实验室,北京102206

出　　处：《中国药业》2021年第12期10-13,共4页China Pharmaceuticals

摘　　要：目的提高药品进口报验效率。方法分析北京市药品检验所2015年至2019年的药品进口报验资料存在的主要问题,提出提高药品进口报验资料质量的可行性建议。结果2015年至2019年,存在问题的药品进口报验单数量占当年药品进口报验单总数的比例介于9.13%~21.43%,主要问题为药品进口通关报验资料不齐全和相应信息有误,需依照相关法律法规进行补充和更正。结论报验人员在准备药品进口报验资料时要耐心、细致,审核人员需依照相关法律法规全面、认真地核对药品进口报验资料,避免出现问题,提高报验效率。Objective To improve the efficiency of drug import inspection.Methods The main problems in the drug import inspection application materials of the Beijing Institute for Drug Control from 2015 to 2019 were analyzed.The feasibility suggestion of improving the quality of drug import inspection application materials was proposed.Results From 2015 to 2019,the ratio of the number of problematic drug importation inspection application to the total number of drug importation inspection application in that year was between9.13%to 21.43%,it contained wrong information and incomplete inspection application materials of drug importation,which needed to supplemented and corrected according to relevant laws and regulations.Conclusion The inspection application personnel should be patient and careful in the preparation of drug import inspection application materials,the inspection application materials auditors should comprehensively and carefully check the drug import inspection application materials following the relevant laws and regulations to avoid problems and improve the efficiency of inspection.

关 键 词：药品进口 报验资料 报验效率 药事管理 

分 类 号：R95[医药卫生—药学]