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 domestic policies and regulations on generic drug development and reporting. Methods: By sorting out the policies and regulations promulgated in the near future, we analyzed the policy changes related to generic drug development and gave corresponding suggestions for development. RESULTS AND CONCLUSION: In view of the possible impact of the current policy changes on the development of generic drugs, some suggestions are put forward, hoping to give reference to other domestic generic drug research and development institutions.