国家食品药品监督管理总局于2016年调整了化学药品注册分类。分析化学药品新旧注册分类中的新药、仿制药概念、内涵以及技术标准的变化。与2007年版法规相比，新法规对新药和仿制药的定义均发生了明显变化，新药的范围缩小，要求更为严格和准确，仿制药的适用范围扩大，在技术标准方面达到国际要求。药品注册制度改革对医药研发产生了深远影响：促使国内医药市场重新洗牌，鼓励企业加大研发和创新力度，加快进入国际市场的步伐。

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.