专利药物在仿制过程中的问题及思考

发布时间：2018-05-12 10:34

  本文选题：审评数量 + 号文件　； 参考：《中国发明与专利》2016年01期

【摘要】：近几年来,我国新药审评数量大幅增加,2015年7月31日,国家食品药品监督管理总局(CFDA)发布了《关于征求加快解决药品注册申请积压问题的若干政策意见的公告》,即140号文件,明确专利药物的仿制申报时间。通过专利分析报告机制让药品审批机构和仿制企业准确掌握专利信息,推动药品申报工作和预警机制的良好运转,鼓励专利挑战性仿制申报,提高我国药品研发水平。
[Abstract]:In recent years, the number of new drug reviews in China has increased substantially. On July 31, 2015, the State Administration of Food and Drug Administration (CFDAA) issued a notice on soliciting some policy opinions on expediting the problem of resolving the backlog of drug registration applications, I. E. document 140. Clear patent drug copy of the reporting time. Through patent analysis and report mechanism, drug approval agencies and imitation enterprises can grasp patent information accurately, promote the good operation of drug application and early warning mechanism, encourage patent challenge imitation application, and improve the level of drug research and development in China.
【作者单位】： 辽宁思百得医药科技有限公司;
【分类号】：R95;G306
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本文编号：1878281