药品上市许可持有人对药品质量安全负主体责任。此文就国内外药品上市许可持有人制度的实施情况进行综述，并对2023年3月1日实施的《药品上市许可持有人落实药品质量安全主体责任监督管理规定》进行研读，进一步评述药品上市许可持有人在开展药品质量管理工作中的责任和要求。

Drug marketing authorization holder takes the main responsibility for drug quality and safety. This paper reviews the implementation of the drug marketing authorization holder system at home and abroad, studies the regulations on the supervision and administration of drug marketing authorization holder implementing the main responsibility of drug quality and safety, which was implemented on March 1, 2023, and further comments on the responsibilities and requirements of drug marketing authorization holder in carrying out drug quality management.