Research On Marketing Authorization Holder System

Marketing Authorization Holder(MAH)system is an approval and management system of drugs,which is widely adopted by most countries around the world.According to the system,marketing licensor and production licensor can be the same subject body or two independent subject bodies.In 2019,the Drug Administration Law is comprehensively revised in China.Before the revision,drug approval system adopts the approval and management system of combining drug marketing license and production license.With the increasingly fierce international competition in the pharmaceutical industry,the original drug approval and management system led to problems such as excess capacity and waste of resources in pharmaceutical manufacturing industry.China has necessity and condition to establish MAH system.In 2019,MAH system is formally established in the new Drug Administration Law and is designed on the basis of referring to foreign advanced systems and combining with actual conditions in China,so it’s full of Chinese characteristics.The establishment of such system has its legal basis and historical background.With the establishment of the new system,MAH system is also facing great challenges on the basis of lack of supporting legal systems.First,the thesis analyzes the evolution of drug approval system and the background of the establishment of MAH system in China;analyzes the basis of establishing MAH system from the perspective of the embodiment of legal value and practical conditions;collates and analyzes the domestic and foreign laws and regulations in connection with MAH system and compares the system and practice in the European Union,the United States and Japan and.Second,the establishment of MAH system puts forward new requirements for administrative supervision in China.This thesis studies the new problems faced by the administrative supervision in the process of entrusted production and after the drug listing under MAH system.Starting from the new changes and difficulties in the supervision,through analyzing the experience of overseas supervision and the enlightenment in the process of system pilot,the thesis provides suggestions for the improvement of supervision.Third,based on the new problems faced by the civil liability after establishment of MAH system,through the analysis of the results and enlightenment in the pilot process,the thesis provides suggestions for the development of this system in China.MAH system means opportunities and challenges for pharmaceutical enterprises.With the expansion of subjects of drug license application,the diversification of cooperation mode and the participation of different types of enterprises in every link,it calls for new requirements and put forward challenges for the capacity and efficiency of regulatory agencies.With more strict and efficient supervision,the drug approval and management system will become more and more perfect in China and encouraging innovation and strengthening supervision will become harmonious and united.