Study On Improving The Protection System Of Biotech Drugs Test Data In China

The drug test data, refers to the test data obtained at various stages of drugdevelopment. These data are used to determine the drug efficacy, safety and qualitycontrol, with its commercial value is mainly embodied in generics drugs（imitationpharmaceuticals）.In the context of traditional medicines, assuming that if there is no drugdata protection system, generic drug manufacturers can directly use the originalmanufacturer’s pharmaceutical research and drug data to prove to prove its drug safety,efficacy, and pharmaceutical data protection systems arising therefrom.The effectivecomponents of conventional generic drug is simple, however, the effective components ofbiosimilars is often not a single molecule, so, the effective components of biosimilars andoriginal type of biopharmaceutical products basically impossible to do exactly the same,there are no corresponding analysis techniques to verify its bioequivalence. Biosimilarscan only be an infinite close to the original drug. Under the scientific problems, how todesign a rational system of biological drug data protection, has become the urgent problemof biosimilars industry. This paper tries to expound the connotation of special dataprotection system for drugs and biological drugs, a comprehensive comparison of learningfrom foreign legislative experience, combined with China’s situation, to put forwardrecommendations for China to develop biological drug data protection system.