| 杨月明,杨红玉,廖剑波,等.我国药品生产企业个例药品不良反应收集现状及其思考[J].安徽医药,2018,22(10):2019-2021. |
| 我国药品生产企业个例药品不良反应收集现状及其思考 |
| ADR case report of the domestic pharmaceutical manufacturing enterprises:Status quo and reflections |
| 投稿时间：2017-05-03 |
| DOI： |
| 中文关键词: 药物副反应报告系统 制药工业 登记 问题解决 |
| 英文关键词: Adverse drug reaction reporting systems Drug industry Registries Problem solving |
| 基金项目: |
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| 摘要点击次数: 2248 |
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| 中文摘要: |
| 分析我国药品生产企业个例药品不良反应监测能力不足、上报意识不强等现状,借鉴美国、欧盟药品生产企业收集个例药品不良反应方法和经验,探讨既符合我国法律法规要求,又适应国内药品生产企业实际情况,能够切实可行的提高生产企业个例药品不良反应收集水平的对策。 |
| 英文摘要: |
| This paper analyzed the present status of insufficient monitoring capacity and lack of a sense of ADR reporting in domestic pharmaceutical manufacturing enterprises,and by drawing on relevant good practices in EU and USA,this paper proposed a new methodology to improve the ADR case reporting level for domestic pharmaceutical manufacturers.The proposed methods are in comformity to the requirements of the laws and regulations in China,and are also practical to implement for the industries as well. |
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