Study On The Impact Of Drug Registration System Reform On New Drug Research And Development In China

Objective: This paper systematically sorts out the main contents of China’s new round of drug registration system reform,clarifies the main characteristics of institutional reform and its impact on new drug research and development,and provides suggestions for promoting new drug research and development in China based on the current situation of China’s research and development and reform environment.Methods:This paper mainly adopts literature research method,qualitative analysis method,statistical analysis method and other research methods.Firstly,the literature research method is used to read the articles related to the research content,and the new drug research and development system in China is constructed according to the theory of the national innovation system,and the current situation of new drug research and development in China is examined from five aspects: industrial overview,R&D subject,R&D elements,value creation and institutional environment.Secondly,the qualitative analysis method is used to sort out the current research results and policy texts,summarize the main contents of the new round of drug registration system reform in China from 2015 to 2020,and analyze the main characteristics of drug registration system reform from a macro perspective based on the new public management theory.Finally,the statistical analysis method is used to process the collected data,sort out the data related to new drug research and development,analyze the impact of reform on new drug research and development,and make suggestions for improving the level of new drug research and development in China.Results:(1)According to the theory of national innovation system,the framework of China’s new drug research and development system is constructed,and the current situation of new drug research and development in China is analyzed from the three aspects of R&D subjects,R&D elements and value creation,and it is found that China’s new drug R&D subjects still face challenges such as lack of technological innovation and insufficient investment in R&D factors,there is still a certain gap between value creation results and developed countries,and the reform of the institutional environment has a positive effect on the development of the new drug R&D industry.(2)Based on the perspective of new public management,analyze the main characteristics of the drug registration system and related regulations adjustment,mainly in the following five aspects:pay attention to clinical value,strict examination and approval,deepen the simplification of administration and decentralization,introduce competition mechanism and promote electronic government affairs;The impact of the reform of the drug registration system on the new drug R&D industry mainly clarifies the orientation of new drug R&D;Improved approval standards;Stimulated the innovative vitality of R&D;Alleviate low levels of duplication;Five aspects such as reducing the policy cost of research and development.(3)The policy environment and R&D elements jointly provide support and services for R&D entities to create value results,and the two promote and interact with each other,which is an inexhaustible driving force for the development of new drug R&D system.Conclusion:Under the background of the national innovation and development strategy,the benign development of the new drug innovation system should not only provide policy guidance for the innovation subjects,but also provide a good R&D environment for drug innovation by increasing the investment of innovation factors and the construction of facilities,so as to ensure the health of people’s drug use and meet people’s drug needs,and enhance the international competitiveness of China’s pharmaceutical industry.