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專利藥物在仿制過程中的問題及思考

發(fā)布時間:2018-05-12 10:34

  本文選題:審評數(shù)量 + 號文件 ; 參考:《中國發(fā)明與專利》2016年01期


【摘要】:近幾年來,我國新藥審評數(shù)量大幅增加,2015年7月31日,國家食品藥品監(jiān)督管理總局(CFDA)發(fā)布了《關(guān)于征求加快解決藥品注冊申請積壓問題的若干政策意見的公告》,即140號文件,明確專利藥物的仿制申報時間。通過專利分析報告機制讓藥品審批機構(gòu)和仿制企業(yè)準確掌握專利信息,推動藥品申報工作和預警機制的良好運轉(zhuǎn),鼓勵專利挑戰(zhàn)性仿制申報,提高我國藥品研發(fā)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.
【作者單位】: 遼寧思百得醫(yī)藥科技有限公司;
【分類號】:R95;G306
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本文編號:1878281

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