关键词: font-size:medium, ">药物警戒质量管理规范；药物警戒体系；上市许可持有人；药品管理法

Abstract: The newly revised Drug Administration Law of the People′s Republic of China establishes the legal status of the pharmacovigilance system in China.The release of the first edition of “Good Pharmocovigilance Practice”（GVP） in China also promoted the construction of pharmacovigilance capacity.Establishing and improving pharmacovigilance system is a major issue and challenge that needs to be resolved urgently by the national drug regulatory agencies and drug marketing authorization holders (MAH).At present, the establishment of pharmacovigilance system of most of the MAH was based on the concept of “adverse drug reactions (ADR)”. The organizational structure, staffing, responsibilities, scope of work, and objects of work within the system are no longer able to meet the regulatory requirements in the scope of pharmacovigilance.This research combines the practical experience of the enterprise, and from the aspects of pharmacovigilance system concept transformation,organizational structure, staffing, functional scope, document system, etc.，to discuss how to build a comprehensive pharmacovigilance system that meets regulatory requirements for MAH, and puts forward related construction ideas，so as to provide reference for MAH to establish and improve the pharmacovigilance system.

Key words: Good Pharmocovigilance Practice;Pharmacovigilance, Pharmacovigilance system;Marketing authorization holder;Drug Administration Law of the People's Republic of China