化学仿制药新法规对研发及注册管理的影响分析

Influence of new registration on chemical generic drug R&D and registration management

国家食品药品监督管理总局于2015年调整了化学药品注册分类。本文分析了我国仿制药概念的变更情况,比较了新旧法规对仿制药定义、注册程序、技术要求的异同,并与国外药监部门的监管要求进行了比较。与2007年版法规相比,新法规对仿制药的定义、申请程序等均发生了明显变化,对仿制药的限定条件更为严格和准确,仿制药概念的适用范围有所扩大。新法规结合当前我国药品研发的现状,进一步精简了药品注册申报程序。在技术要求方面,保持与国际通行的标准相同,体现了全程控制、质量源于设计、风险控制等理念。法规的变化将对仿制药的研发和注册申请产生深远的影响。

The China Food and Drug Administration（ CFDA） modulated the Drug Registration Regulations at 2015. The concept change of the generic drug in China was analyzed. The definition,registration process and the evaluation standard of generic drug in the two copies of the regulations were compared,and they also compared with the drug administration abroad. Compared with the 2007 version of regulations, obvious changes have happened; the definition is more strict and accurate,and the scope of generic drugs has been expanded. Aaccord to the current situation of drug RD in China,the registration process is simplified. The new regulation keeps the same evaluation standards with the ICH,FDA and EMA,embodying the whole process control,quality by design,risk control and other concepts. Regulatory changes will have a profound impact on the development and application of generic drugs.