Research On The System Of Drug Test Data Protection

The drug test data is of great commercial value.At the same time,it has a potential impact on the social public health and the continuous development of the pharmaceutical industry.Because of the reform of the registration and approval system of generic drugs,the registration and approval of generic drugs require experimental data on new drugs.The data of the drug test will be easily exposed.To maintain the interests of the new drug developers and the normal order of the pharmaceutical innovation industry,the protection of drug test data is indispensable.The relationship between the drug test data protection system and the patent protection system is parallel.The TRIPS protocol has identified the minimum international standards for protecting drug test data at the international level.The drug test data must meet the following 4 conditions in order to be protected by the TRIPS:1.It is the drug test data that must be submitted for the approval of the listing;2.Use the new chemical composition;3 Make a great effort;4.Undisclosed.In consideration of the legislative practice of drug test data protection in various countries,compare with the scope of application of drug test data protection in various countries,and come to conclusion:1.The medical innovation ability of various countries;2.The state’s drug registration and approval system;3.The restrictive conditions set by the pharmaceutical department;4.The level of drug availability in the country.With the biological medicine in the world the rapid development of biological products,test data protection has become the focus of attention in recent years,some developed countries have established a biological test data protection system,have a reference value for China’s future development of bio industry.Analysing the status of drug test data protection system in China,and put forward some suggestions for perfection.1.Phased protection of China’s drug test data protection period.2.Extending the time limit for the protection of experimental data of rare drugs and children’s drugs on the original basis.3.Carrying out the reform of biological generic drugs.4.Traditional Chinese medicine:Integrating traditional Chinese medicine with a certain degree of innovation into the scope of drug data protection.