2009年SFDA批准注册的国产化学药品统计分析

目的了解和分析2009年我国新注册的化学药品分布情况。方法全面检索国家食品药品监督管理局数据库和相关资源,登记2009年注册的国产化学药品的名称、批准文号、药物化学治疗分类、是否属国家基本药物等,然后运用Excel进行分类汇总分析。结果 2009年共注册国产化学药品1 583个,涉及通用名药物489个,药品批准文号数量排序前三位的依次为抗微生物药物、作用于中枢神经系统的药物和作用于消化系统的药物。结论 2009年国产化学药品注册依然存在药品注册与需求不完全一致、个别药品"一药多号"、抗微生物药物生产竞争激烈等问题,同时也出现基本药物注册小高峰等新迹象。

Analysis of chemical drugs registered by State Food and Drug Administration in 2009

Objective To investigate and analyze the distribution of chemical drugs registered by State Food and Drug Administration(SFDA) in 2009. Methods The data of registered chemical drugs in 2009 including names, approval numbers, medication classifications and whether it belongs to national essential drugs or not were collected from SFDA website. Statistical analysis was implemented by Excel. Results 1 583 chemical drugs were registered which involved 489 generic chemical drugs. The most registered drugs according approval numbers were antibacterial agents, central nervous system agents and digestive system agents in turn. Conclusion The situation of chemical drugs registration in 2009 was still unsatisfied. The distribution of registration categories couldn't meet the requirement of public. The same generic drug had too much approval numbers. The productions of Antibacterial agents were competitive. A new indication of small climax of essential drugs registration appears at the same time.