Drug data protection system is an intellectual property system which is created by thegovernment to get balance between cheap medication and stimulation of innovation.Anprerequisite of this system is that generic drugs on behalf of the cheap drugs and originalmedicine have the same security and effectiveness.Traditional chemicals,having smallmolecules,can be repetitive,and its generic drug is almost the same performance withoriginal drug.Biopharmaceutics have very special characteristics, and there is a cleardifference in the application of this system.Thus, it is not feasible that data protectionsystem not applied to Biopharmaceutics completely or fully applicable by traditionalchemic methods. Our country should analyz the particularity of the data protection ofBiopharmaceutics rationally,drawing on the modes of biopharmaceutical data protectionof EU and the United States,combining with China’s devel opment,and then legislate.Biopharmaceutics data protection system in line with China’s Biopharmaceutics industry.,... |