FDA警告信给中国药品生产企业的启示  

Enlightenment of FDA Warning Letterto Chinese Drug Manufacturers

作　　者：孙绪 惠丰 Sun Xu;Hui Feng(Yantai Rongchang Pharmaceutical Co.,LTD,Yantai,264000,China;Rongchang Bio-pharmaceutical(Yantai)Co.,LTD.,Yantai,264000,China)

机构地区：[1]烟台荣昌制药股份有限公司,山东烟台264000 [2]荣昌生物制药(烟台)股份有限公司,山东烟台264000

出　　处：《药学进展》2024年第9期716-720,I0003-I0006,共9页Progress in Pharmaceutical Sciences

摘　　要：通过对美国食品药品监督管理局(FDA)官网2019年1月—2023年12月警告信数据库进行检索,从FDA检查地理分布及趋势、发给中国企业警告信缺陷项统计等多维度进行整理分析,提出思考与建议,希望为我国药品生产企业接受FDA检查提供相应的经验与启示,做到把握检查趋势,关注检查重点,为我国药品走向国际市场打好基础。Through searching the warning letter database of the US Food and Drug Administration(FDA)oficial website from January 2019 to December 2023,this paper sorts out and analyzes the geographical distribution and trend,and the statistics of warning letter defects issued to Chinese enterprises,putting forward some thoughts and suggestions,in the hope of providing corresponding experience and enlightenment for China's drug manufacturers to pass FDA inspection,grasping the inspection trend,paying attention to the inspection focus,and laying a good foundation for China's drugs to enter the international market.

关 键 词：缺陷项 药品检查 警告信 药品生产企业 

分 类 号：R95[医药卫生—药学]