中美两国抗菌药物产品目录比较

Comparison of Antibacterial Agent Products Directory between China and America

目的:了解中美两国抗菌药物产品目录的差异,为相关部门提供参考。方法:结合国家食品药品监督管理总局网站公布的国产与进口药品数据和美国FDA网站中的美国国家药品代码目录(NDC),对比分析两国抗菌药物品种数、品规数、产品数、儿童剂型以及生产企业集中度的差异。结果与结论:中美两国抗菌药物产品目录中,抗菌药物品种数分别为191、84个,品规数分别为460、1 392个,产品数分别为23 824、3 139个;儿童剂型分别为51、26个;产品数列前10位的抗菌药物生产企业的产品数分别占各自总产品数的6.29%和33.67%,表明我国抗菌药物品种数、品规数虽然较丰富,但集中度较低。建议我国相关部门对抗菌药物的批准和生产实施严格审批和监管,同时对已上市产品进行重新遴选和评价,采用价格或市场机制,优胜劣汰。

OBJECTIVE：To investigate the differences of antibacterial agent products directory between China and America,and to provide reference for the relevant departments. METHODS：Using domestic and imported drug data released by China Food and Drug Administration（CFDA）and national drug code（NDC）issued by America Food and Drug Administration（FDA）,antibacterial drugs of China and America were analyzed comparatively in respects of types,specification,the number of products,child-size dosage form,concentration ratio of manufacturers. RESULTS CONCLUSIONS：In CFDA＇s and FDA＇s directory of antibacterial drugs,the number of type,specification and product were 191 and 84,460 and 1 392,23 824 and 3 139,respectively. The number of child-size dosage form were 51 and 26. The number of products in enterprises with the top 10 product number accounted for 6.29% and 33.67%. In China,the type and specification of antibacterial drugs are abundant but low. It is recommend that antibacterial drugs＇ approval should be examined and supervised strictly. At the same time,products already marketed should be reselected and revaluated,and price or market mechanism should be adopted to promote the survival of the fittest of antibacterial drugs.