药品上市许可持有人开展药物警戒工作的现状及建议

Status and Suggestions of Pharmacovigilance Carried out by Marketing Authorisation Holder

目的:为我国药品上市许可持有人开展药物警戒工作提供建议和参考。方法:结合现行的法律法规,对我国药品上市许可持有人开展药物警戒工作存在的问题进行归纳分析,提出相应建议。结果:我国药物警戒的法规体系日趋完善,信息监测系统逐步成体系,但部分药品上市许可持有人认识不到位,未设立专门的药物警戒机构,未配备人员。结论:药品上市许可持有人的药物警戒体系建设仍需加强。

Objective:To provide suggestions and references for marketing authorization holders(MAH)during the pharmacovigilance.Methods:Combined with the current laws and regulations,the issues existing in pharmacovigilance work of MAH in China were summarized and analyzed,and corresponding suggestions were put forward.Results:The legal system of pharmacovigilance in China is becoming increasingly perfect,and the information monitoring system has gradually become a system.But some MAH still don’t have a good understanding of pharmacovigilance,and there is no special pharmacovigilance institution and relevant personnel.Conclusion:The construction of the pharmacovigilance system for MAH still needs to be enhanced.