摘要
目的通过介绍药品上市许可持有人(MAH)药物警戒体系的建立内容及相关思考,为药物警戒工作开展与监管提供参考。方法结合法律法规要求和企业实际情况,对药物警戒工作开展现状与存在问题进行归纳与分析,并提出设想和思考。结果 MAH建立药物警戒体系存在紧迫性和必要性;药物警戒工作对患者安全和企业安全意义重大。结论 MAH应加快建立健全药物警戒体系,有效开展药物警戒活动。
Objective To provide reference for the development and supervision of pharmacovigilance by introducing the establishment of MAH pharmacovigilance systems and related considerations. Methods In combination with laws and regulations as well as the actual situation of enterprises, we summarized and analyzed the status quo of and problems with pharmacovigilance, and presented our views. Results It’s necessary and urgent for MAHs to establish pharmacovigilance that is of great significance for the safety of patients and businesses. Conclusion It is vital for MAHs to speed up the establishment of a sound pharmacovigilance system in order to make pharmacovigilance more effective.
作者
陈灿灿
陈伟
张亚男
胡晓光
李万军
CHEN Cancan;CHEN Wei;ZHANG Yanan;HU Xiaoguang;LI Wanjun(Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,Hefei Anhui 230088,China)
出处
《中国药物警戒》
2020年第8期474-479,共6页
Chinese Journal of Pharmacovigilance
关键词
药品上市许可持有人
药品
药物警戒体系
建立
marketing authorization holder
drug
pharmacovigilance system
establishment
