Research On The Problems And Countermeasures Of The Drug Marketing Authorization Holder System

The revision of the "Drug Administration Law" in 2019 marks the official implementation of our country’s Drug Marketing Authorization Holder system.Affected by the characteristics of regional development,pharmaceutical companies in Suzhou have strong research and development capabilities,weak industrial production capacity,and serious technological achievements outflow.The implementation of the MAH system has provided new opportunities for the development of the pharmaceutical industry in Suzhou.This paper mainly adopts literature research method,institutional survey method,questionnaire and interview method,and uses Smith ’s policy implementation process model as the analysis framework of the paper.Based on the four aspects of policy itself,policy implementation agency,policy target group and policy environment,the new public management theory and path dependence theory are used to analyze the problems and causes in the process of policy implementation.Through data and data analysis,it is found that there are five problems in the implementation of the policy in Suzhou,such as the difficulty of cross-regional entrusted production supervision,the lack of precise publicity of policy enforcement agencies,the small coverage of support policies,the lack of timely and effective information communication among policy target groups,and the lack of post-marketing management and risk-taking ability of policy target groups.The main reasons for the above problems are that the policy rules and supervision mechanism need to be improved,the policy implementation agencies fail to actively adapt to the transformation and development of the policy,the policy target groups fail to actively break through the inherent mode and the adverse factors of the policy environment.Through the analysis of the experience of policy implementation in other cities in China,this paper puts forward the optimization countermeasures of policy implementation from the following four aspects.Firstly,we should improve the policy rules and supervision mechanism from the national level.Secondly,we should improve the execution ability of policy implementation agencies and stimulate the subjective initiative of target groups.At the same time,we need to optimize the policy environment and improve the core competitiveness.Suzhou has continuously implemented the implementation of the MAH system since the pilot work of the MAH system began in 2016.The Suzhou government has taken a series of measures and achieved certain results.Through the analysis of the problems and causes of the implementation of the drug marketing license holder system in Suzhou,and drawing on the experience of policy implementation in other cities in China,reasonable optimization countermeasures are proposed to provide practical experience for the implementation and gradual improvement of the drug marketing license holder system in Suzhou and even the whole country.