| With the growing of the health industry,the pharmaceutical industry has attracted more and more attention from the people and the country.Pharmaceutical outsourcing started relatively late in our country,and there are still many problems in actual production,which led to the emergence of policies.In December 2019,the new Drug Administration Law came into effect,and the marketing authorization holder(MAH)system began to be implemented.The MAH system has brought new opportunities to the development of new drug R&D and commissioned production,and will also bring the new problem.how to ensure the quality of entrusted drugs under the MAH system.Therefore,this thesis focuses on the three main bodies of the drugs in the commissioned production,and discusses the countermeasures to improve the quality of the commissioned drugs,so as to increase the quality and safety of the commissioned drugs in the market.First this thesis systematically expounds the basic theories such as drug-related concepts,principal-agent theory,and evolutionary game.Second,it analyzes the current situation of drug production quality and supervision under the MAH system,including the supervision of the entrusting party and the government,and puts forward the problems existing in the current quality and supervision.Considering the regulatory autonomy of the entrusting party and the mandatory and high cost of government regulation under the MAH system,this article analyzes from two aspects:The first is to build a principal-agent model for the compliant production of pharmaceutical products based on the principal-agent theory,regardless of government supervision,and combine examples to studies the incentive and supervision mechanism of drug marketing authorization holders for the entrusted production enterprises and analyze the factors that affect the level of compliant production in the commissioned production under this model.The study found that The incentives,supervision,cost of compliant production,and benefits of immoral behavior are the key factors that affect the compliant production level of entrusted production enterprises.For different influencing factors,both sides of the entrusted production should adopt different strategies,so as to improve the level of compliant production of drugs and obtain greater benefits.The second is to comprehensively consider the actual situation of the existing government regulatory authorities,mainly analyze the strategy evolution process of government supervision departments,drug marketing license holders,and entrusted production enterprises,and solve the evolution and stability strategy of the system according to the strategic benefits of the three parties in the game and the replication dynamic equation.analyze the evolution law of the respective strategies of both sides of the game,and use Matlab software to carry out numerical simulation of the established evolutionary game model.The research finds that the supervision strength of the government supervision department,the speculative income of the entrusted production enterprises and the supervision of drug marketing license holders Costs and social benefits will have a greater impact on the stability strategies of all parties.In order to ensure the quality of drugs,the three parties should have different countermeasures to make the system develop in a stable and sound direction.This thesis analyzes the game among the three subjects in the commissioned production under the MAH system,studies the quality supervision of drug commissioned production under the two conditions of no government supervision and government supervision,and analyzes the factors that affect the stability strategy.Then,starting from the influencing factors,it proposes targeted strategies from the perspectives of enterprise management,contract design,and government supervision,etc.,to provide suggestions for the quality improvement of drug commissioned production,and development of drug quality supervision. |
