近期国内政策法规变动对仿制药研发和申报的影响

Impact of Recent Changes in Domestic Policies and Regulations on the Development and Application of Generic Drugs

目的:探讨国内政策法规变动对仿制药开发和申报的影响。方法:通过整理近期出台的政策法规,分析其中与仿制药开发相关的政策变化,给予相应的开发建议。结果与结论:针对当前政策变化对仿制药开发带来的可能影响,提出一些建议,希望能给国内其他仿制药研发机构予以参考。

Objective： To explore the impact of recent changes in domestic policies and regulations on the development and appli- cation of generic drugs. Methods： Through the collation of the recent regulatory documents, the policy changes for generic drugs were analyzed, and the corresponding development proposals were provided. Results and Conclusion： According to the possible impact of current policy changes on generic drug development, the relative solutions are proposed with the aim to provide certain reference for ge- neric pharmaceutical R ＆ D institutions.