國家食品藥品監(jiān)督管理總局于2016年調整了化學藥品注冊分類。分析化學藥品新舊注冊分類中的新藥、仿制藥概念、內涵以及技術標準的變化。與2007年版法規(guī)相比，新法規(guī)對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，要求更為嚴格和準確，仿制藥的適用范圍擴大，在技術標準方面達到國際要求。藥品注冊制度改革對醫(yī)藥研發(fā)產生了深遠影響：促使國內醫(yī)藥市場重新洗牌，鼓勵企業(yè)加大研發(fā)和創(chuàng)新力度，加快進入國際市場的步伐。

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.