國(guó)家食品藥品監(jiān)督管理總局于2016年調(diào)整了化學(xué)藥品注冊(cè)分類。分析化學(xué)藥品新舊注冊(cè)分類中的新藥、仿制藥概念、內(nèi)涵以及技術(shù)標(biāo)準(zhǔn)的變化。與2007年版法規(guī)相比，新法規(guī)對(duì)新藥和仿制藥的定義均發(fā)生了明顯變化，新藥的范圍縮小，要求更為嚴(yán)格和準(zhǔn)確，仿制藥的適用范圍擴(kuò)大，在技術(shù)標(biāo)準(zhǔn)方面達(dá)到國(guó)際要求。藥品注冊(cè)制度改革對(duì)醫(yī)藥研發(fā)產(chǎn)生了深遠(yuǎn)影響：促使國(guó)內(nèi)醫(yī)藥市場(chǎng)重新洗牌，鼓勵(lì)企業(yè)加大研發(fā)和創(chuàng)新力度，加快進(jìn)入國(guó)際市場(chǎng)的步伐。

The China Food and Drug Administration (CFDA) modulated the Drug Registration Regulation at 2016. In this article, the registration classification of chemical drug was analyzed, and the definition, connotation and technical standard of new drugs and generic drugs were compared. Compared with the 2007 version of regulations, obvious changes have happened, the scope of new drugs has been narrowed, and the definition is more strict and accurate, the scope of generic drugs has been expanded. The new regulation keeps the same evaluation standards with the ICH, FDA and EMA. Regulatory changes have a profound impact on the medical research and development:promoting the reformulation of domestic pharmaceutical market, encouraging R&D and innovation in enterprises and accelerating the pace towards the international market.