By analyzing the legal qualification of unqualified vaccines in Changchun Changsheng’s vaccine event, this paper revealed unscientific and unreasonable problems in the definition of counterfeit and inferior medicines in current drug laws of China. In addition, combined with the specific provisions of Criminal Law on the criminal responsibility for the production and sale of counterfeit and inferior medicines, this paper elaborated the dilemma faced by unqualified vaccines in judgment of qualitative and criminal responsibility in this event. Meanwhile, the paper focused on the focal problems in this event and drew on the classification of unqualified drugs by American Pharmaceutical Law. Finally, it proposed the concept that counterfeit drugs should be defined scientifically and whether to comply with the GMP should be as one of the criteria for determining counterfeit drugs, and to increase criminal penalties for illegal production and sale of fake vaccines.