美国FDA新版《全身用抗菌药品和抗菌敏感性试验装置说明书的敏感试验资料指导原则》内容简介  

Introduction of the Guidance for Industry "Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices" Released by US FDA

作　　者：李雪梅[1] 萧惠来[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国药事》2012年第5期517-520,共4页Chinese Pharmaceutical Affairs

摘　　要：目的介绍美国食品药品管理局(FDA)新版《全身用抗菌药品和抗菌敏感性试验装置说明书的敏感试验资料指导原则》的要点,希望对我国抗菌药品说明书中该部分内容的撰写、使用和监管有所启迪。方法抗菌药品生产企业可参考该《指导原则》,及时更新药品说明书中的抗菌药敏感性资料内容,将抗菌药敏感性试验结果及时准确的告诉医生,以选择合适的抗菌药治疗感染性疾病,减少耐药性的发生。结果该《指导原则》能有效地指导生产抗菌药品的企业撰写及更新抗菌药敏感试验资料。结论抗菌药物敏感性试验结果是抗菌药品说明书中的重要内容,为指导医生患者合理用药,减少抗菌药耐药性的蔓延,该项内容应引起相关药品生产企业、医生及药品监管部门的高度关注。Objective To introduce main points of the Guidance for Industry ＂Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices＂ released by US FDA. It could be helpful for the writing, using and regulation of the relevant parts in the antibacterial drug information leaflet. Methods With these referral guidelines, antimicrobial drug manufacturers may update the antimicrobial susceptibility data in drug information leaflets and provide the antimicrobial susceptibility test results to healthcare professionals timely and accurately, so as to contribute to the appropriate selection of antibiotic drugs for infectious diseases and reduction of the drug resistance. Results The guidelines can effectively direct the antimicrobial drug manufacturers in writing and updating information on antimicrobial susceptibility testing. Conclusion Antimicrobial susceptibility test results are important parts in antimicrobial drugs ~ information leaflets. Relevant pharmaceutical manufacturers, doctors and regulatory authorities in China should pay more attention to antimicrobial susceptibility test results in order to rationally use drugs and reduce the antimicrobial resistance.

关 键 词：抗菌药物 药物敏感性试验 药品说明书 

分 类 号：R915.11[医药卫生—微生物与生化药学] R956.13[医药卫生—药学]