After four years of piloting，Medicinal Product Administration Law of the People’s Republic of China （2019 Revision） formally established a Marketing Authorization Holder System. Practice has proved that it is a powerful promoter of encouraging pharmaceutical innovation. As a drug review and approval system that has achieved good results internationally，the drug marketing authorization holder system has many advantages. However，because of its complete break of the previous “bundled” management model，it will pose challenges to the ability of license holders and the existing regulatory system，and there are certain institutional risks at this stage. To continue to promote the drug marketing license holder system，we should face up to the problems and establish corresponding supporting mechanisms in light of our country’s actual conditions to promote the continuous development of our country’s pharmaceutical industry.