美国法上药品注册审批制的伪装请愿是指一种原研药企业利用政府行为本身作为一种延缓仿制药企业进入市场的手段,伪装请愿的产生有诸多原因。结合我国药品注册审批制的立法现状,美国法上解决伪装请愿的分析路径对解决我国目前药品注册审批制存在的问题具有借鉴意义。 The camouflage petition of the drug registration and approval system in the United States Act refers to the fact that an original drug manufacturer used the government act itself as a means of delaying the entry of generic drug companies into the market. There are many reasons for the disguise of a petition. Combining with the legislative status quo of drug registration and approval system in our country, the analysis of the analysis of camouflage petitions in the United States has a reference to solve the existing problems in the examination and approval system for drug registration in our country.