关于药品上市许可持有人建立药物警戒体系的探讨和思考

Discussion on the Establishment of Pharmacovigilance System for Marketing Authorization Holder

新修订的《中华人民共和国药品管理法》确立了药物警戒制度在我国的法定地位,我国首版《药物警戒质量管理规范》(GVP)的发布也推动了我国药物警戒能力的建设。建立健全我国药物警戒制度和体系是当前药品监管机构和药品上市许可持有人(MAH)亟待解决的重大问题和挑战。当前大多数药品MAH关于药物警戒体系的构建工作是基于“药品不良反应”概念认知层面上展开,体系内组织机构设置、人员配备、职责权限、工作范畴、工作对象无法满足药物警戒范畴的法规要求。本研究结合企业自身实践经验,从药物警戒体系理念转变、组织架构、人员配备、职能范围、文件体系等方面,围绕药品MAH如何构建符合法规要求的、完善的药物警戒体系展开探讨并提出构建思路,以期为药品MAH建立和完善药物警戒体系提供借鉴和参考。

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.