Objective： To explore the necessity and feasibility of drug marketing authorization holder （MAH） and the domestic legal entity designated by oversea drug MAH as the bidding entity for centralized drug procurement after the revision of the Drug Administration Law. Methods： By analyzing the current situation and existing problems of the bidding entities of centralized drug procurement， combined with the drug marketing authorization holder system in China， policy adjustment suggestions for qualification of bidding entity for centralized drug procurement are proposed. Results： After the implementation of the newly revised Drug Administration Law of the People's Republic of China， Drug MAH has become the main quality responsibility subject throughout the entire drug life cycle. The roles of drug manufacturing enterprises and drug MAH have been separated， if drug manufacturing enterprises still being the bidding entity for centralized drug procurement and bearing the full-process responsibility， will face problems such as unclear main responsibilities. Conclusion： It is recommended that drug MAH and the domestic legal entity designated by oversea drug MAH as the bidding entity for centralized drug procurement and assume full process responsibility， further improve the "two-invoice system" policy， and pay attention to the improving of supporting policies for drug MAH as the bidding entity of centralized drug procurement.
