On July 1st, the National Medical Products Administration(NMPA) issued the “Drug Evaluation Report in 2018.” The “Report” shows that the Drug Evaluation Centre of the NMPA reviewed and approved 106 new drugs in 2018. Although the number of applications for registration of new drugs has increased by 47%, the evaluation time has been reduced significantly in comparison to 2017. Benefiting from the accelerated drug evaluation reforms, the number of applications for registration of innovative drugs has increased significantly in 2018, of which 85% were from domestic companies. At the same time, in order to improve the quality of generic drugs, the Drug Evaluation Centre has made every effort to promote the “Quality Consistency Evaluation for Generic Drugs,” and there were eight batches of generic drugs that are involved in comparison to 2018.
《2018年度药品评审报告》发布
来源：中国医药报 2019.07.01
核心提示：7月1日，国家药品监管局发布《2018年度药品评审报告》（以下简称《报告》）。《报告》显示，2018年国家药监局药品评审中心共审评通过106个新药；新药注册申请较2017年增长了47%，但注册申请审评用时明显下降；受益于药审改革加速，2018年创新药注册申请数量大幅增长，其中85%的注册申请来自国内企业；同时，为提升我国仿制药质量，药品审评中心全力推进仿制药治疗和疗效一致性评价工作，2018年全年正式发布了8批参比制剂目录。
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