本文選題：審評(píng)數(shù)量 + 號(hào)文件�。� 參考：《中國(guó)發(fā)明與專利》2016年01期

【摘要】：近幾年來(lái),我國(guó)新藥審評(píng)數(shù)量大幅增加,2015年7月31日,國(guó)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(cè)申請(qǐng)積壓?jiǎn)栴}的若干政策意見(jiàn)的公告》,即140號(hào)文件,明確專利藥物的仿制申報(bào)時(shí)間。通過(guò)專利分析報(bào)告機(jī)制讓藥品審批機(jī)構(gòu)和仿制企業(yè)準(zhǔn)確掌握專利信息,推動(dòng)藥品申報(bào)工作和預(yù)警機(jī)制的良好運(yùn)轉(zhuǎn),鼓勵(lì)專利挑戰(zhàn)性仿制申報(bào),提高我國(guó)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(hào)】：R95;G306
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本文編號(hào)：1878281