Research On The Transfer Of Ownership In The System Of Drug Marketing Authorization Holder

China has been implementing a drug registration license system for drug production licenses and "bundling" the management of drug production licenses and marketing authorizations for many years.Only drug manufacturers with drug approval numbers can qualify for drug marketing authorization.Drug approval numbers are issued only to drug manufacturers that hold Drug Production Licenses,while drug development institutions and other institutions cannot obtain drug marketing authorization.Drug registration license is an administrative license,which is not transferable and therefore has no property rights.With the reform of the market economy system,higher requirements have been imposed on the disposition of civil rights such as pharmaceutical intellectual property rights and marketing permission rights,as well as the rational allocation of pharmaceutical development,production and circulation resources.The drawbacks of original drug registration system have gradually emerged,and the original Drug Administration Law and drug registration management system have not adapted to the need to adjust the relationship and behavior of drug development institutions,drug manufacturers,drug distributors and other relevant entities with regard to the marketing of drugs.In November 2015,in accordance with Decision of the Standing Committee of the National People’s Congress on Authorizing the State Council to Carry Out Pilots of Marketing Authorization Holder System and Related Issues in Some Places,the General Office of the State Council issued Notice on Printing and Distributing Pilot Scheme for Marketing Authorization Holder System,launching pilots of marketing authorization holder system in 10 provinces(cities)in Beijing,Tianjin,Hebei,Shanghai,Jiangsu,Zhejiang,Fujian,Shandong,Guangdong,and Sichuan,piloting marketing authorization holder system,expanding the scope of marketing authorization holders,and enabling entities such as pharmaceutical research institutions to obtain qualifications and corresponding rights for drug marketing authorization,which will have a significant impact on China’s drug management and pharmaceutical economy.By studying on the implementation of marketing authorization holder system,and in accordance with the relevant provisions of marketing authorization holder system in the Drug Administration Law newly revised in 2019,we carried out a key analysis of marketing authorization holder system,conducted a statistical analysis of previous drug technology transfer data,analyzed the rights attributes of holdership in marketing authorization holder system,and discussed the possible problems in the transfer of holdership,with a view to making a pre-judgment on the transfer of holdership in marketing authorization holder system and putting forward reasonable suggestions for the subsequent improvement of marketing authorization holder system.