| 药品上市许可持有人开展药物警戒工作的现状及建议 |
| |
| 引用本文： | 廖辉军,袁兴东,杜传龙,喻文进,王子千,刘良玉. 药品上市许可持有人开展药物警戒工作的现状及建议[J]. 中国药事, 2021, 35(12): 1335-1339 |
| |
| 作者姓名： | 廖辉军 袁兴东 杜传龙 喻文进 王子千 刘良玉 |
| |
| 作者单位： | 江西省药品检查员中心, 南昌 330001 |
| |
| 基金项目： | 江西省药品监督管理局科研项目(编号 2021KY27) |
| |
| 摘 要： | 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...
|
| 关 键 词： | 上市许可持有人 药物警戒 不良反应 现状 建议 |
Status and Suggestions of Pharmacovigilance Carried out by Marketing Authorisation Holder |
| |
| Liao Huijun,Yuan Xingdong,Du Chuanlong,Yu Wenjin,Wang Ziqian,Liu Liangyu. Status and Suggestions of Pharmacovigilance Carried out by Marketing Authorisation Holder[J]. Chinese Pharmaceutical Affairs, 2021, 35(12): 1335-1339 |
| |
| Authors: | Liao Huijun Yuan Xingdong Du Chuanlong Yu Wenjin Wang Ziqian Liu Liangyu |
| |
| Affiliation: | Jiangxi Drug Inspection Center, Nanchang 330001 , China |
| |
| Abstract: | 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 . |
| |
| Keywords: | |
|
| 点击此处可从《中国药事》浏览原始摘要信息 |
|
点击此处可从《中国药事》下载全文 |
|
