关注我国自主研发新药的安全性  

Pay attention to the safety of innovative drugs developed in China

作　　者：方振威[1] 仇琪[1] 林阳[1] Fang Zhenwei;Qiu Qi;Lin Yang(Department of Pharmacy,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China)

机构地区：[1]首都医科大学附属北京安贞医院药事部,北京100029

出　　处：《药物不良反应杂志》2024年第1期2-5,共4页Adverse Drug Reactions Journal

摘　　要：随着我国药品审评审批制度的改革,自主研发新药和附条件批准药物逐年增多。因我国新药上市前临床试验、审评审批制度(尤其是附条件批准制度)和上市后监测管理等方面仍处于不断完善阶段,自主研发新药的安全性需要给予更多的关注,做好其上市后的安全性监测和研究。其中包括加强药物安全性监测工作,做好文献数据的系统性评价,通过高质量真实世界研究广泛收集药品安全性数据,对药物安全性报告数据进行深入挖掘等,为患者安全使用该类药物提供更多的数据支持。Along with the reforms of the assessment and approval regime for new drugs in China in recent years,independently researched and developed innovative drugs and conditionally approved drugs in China have been more and more.The pre⁃market clinical trials,assessment and approval system(especially the conditional approval system),and post⁃market monitoring and management of new drugs in China are still in a continuous improvement stage.Thus we need to specially pay attention to the safety of innovative drugs that independently developed in China and do a good job in post⁃marketing safety supervision.More evidence⁃based information for safe use of this type of medication in patients can be provided through the following aspects:strengthening the drug safety monitoring,conducting systematic evaluation of literature data,widely collecting drug safety data through high⁃quality real⁃world research,and conducting in⁃depth mining of information from drug safety reports.

关 键 词：药物警戒 中国 新药 安全性 药物监测 

分 类 号：R95[医药卫生—药学]