摘要 目的：论证严格以药品上市许可持有人及境外药品上市许可持有人指定履行义务的中国境内法人作为药品集中采购投标申报主体的必要性与可行性。方法：通过分析目前药品集中采购投标申报主体的现状和问题，结合药品上市许可持有人的制度，提出药品集中采购投标申报主体的完善建议。结果：《药品管理法》修订后，药品上市许可持有人成为药品全生命周期质量责任主体，药品生产企业与药品上市许可持有人发生角色分离，仍以药品生产企业等主体为药品集中采购主要投标申报企业并承担全过程责任将面临主体责任不清等问题。结论：建议严格以药品上市许可持有人及境外药品上市许可持有人指定履行义务的中国境内法人为药品集中采购的投标申报主体并承担全过程责任，进一步完善“两票制”政策，并关注药品上市许可持有人作为药品集中采购投标申报主体存在的配套政策完善问题。

Abstract 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 main declarer for centralized drug procurement after the revision of the Drug Administration Law. Method: By analyzing the current situation and existing problems of the main body of Centralized procurement of drugs, combined with the MAH, policy adjustment suggestions for drug centralized procurement declarer are proposed. Result: After the revision of the Drug Administration Law, Drug MAH have become the main legal body responsible for the quality of the entire life cycle of drugs. Drug manufacturer and Drug MAH have separated their roles, and there are still certain problems with drug manufacturer and other entities being the centralized procurement Declarer for drugs and assuming full process responsibility. Conclusion: It is recommended to Drug MAH and the domestic legal entity designated by Oversea Drug MAH as the Declarer for centralized drug procurement and assume full process responsibility, further improve the "Two invoice policy" policy, and pay attention to the new problems caused by Drug MAH(MAH) as the Declarer for centralized drug procurement.