Research On The Protection Of Drug Test Data

Drug test data is the test data that the drug regulatory authorities require new drug developers to submit when applying for new drug registration in order to ensure drug safety.This article discusses the protection of drug test data because the process of drug testing by new drug developers is high investment,high risk,and long cycle,while generic drug applicants only need to refer to the new drug for bioequivalence verification,and indirectly rely on the test of the new drug data can be applied for marketing,so that generic drugs can seize the market at low prices.Therefore,protecting the interests of new drug developers by protecting drug test data is an important measure to stimulate drug innovation.However,based on public health considerations,generic drugs should also be given.Some suitable data usage space for pharmaceutical production entities to ensure drug accessibility.Our country joined the World Trade Organization in 2001 and promised to fulfill the test data protection obligations of member states and introduce the drug test data protection system into my country significance.Nowadays,pharmaceutical innovation is the general trend,and my country has also accelerated the reform and improvement of the drug management system.With the fourth revision of my country’s "Patent Law" and the exploration of an early resolution mechanism for drug patent disputes,systems such as drug patent term compensation and drug patent linking have officially entered the law,and drug trial data protection has been implemented as a supporting system.It should also be constructed and improved as soon as possible.Article 56 of the Regional Comprehensive Economic Partnership(RCEP),which came into effect on January 1,2022,also reiterates the protection of undisclosed information...It can be seen that it is imperative to improve the legal protection of drug test data in my country.This paper sorts out the development and changes of my country’s drug regulatory laws and regulations,focuses on the relevant laws and regulations on the protection of experimental data,analyzes the current status of the system in my country,and summarizes the existing problems.Help improve my country’s drug trial data protection system.This paper believes that my country should actively improve the substantive legal regulations,clarify the scope,method,and time limit of experimental data protection;at the same time,it should improve the program design and improve the practicality of the system;actively explore feasible paths for data disclosure,and unblock information publicity channels;my country should not only increase efforts to encourage new drug research and development,but also attach importance to the development of the generic drug industry,strictly control consistency evaluation,and ensure the quality and efficacy of generic drugs.In order to effectively balance the relationship and contradiction between innovation and imitation,and promote the prosperity and development of my country’s pharmaceutical industry.