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| 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 |
| 投稿时间：2021-08-24 修订日期：2021-11-16 |
| DOI： |
| 中文关键词: 上市许可持有人（Marketing Authorisation Holder，MAH） 药物警戒 不良反应(Adverse Reactions,ADR) 现状 建议 |
| 英文关键词: Marketing Authorisation Holder(MAH) Pharmacovigilance Adverse Reactions(ADR) Status Suggest |
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| 中文摘要: |
| 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：药品上市许可持有人的药物警戒体系建设仍需加强。 |
| 英文摘要: |
| Objective Analysis and thinking of the current implementation situation of pharmacovigilance in China were carried out to provide suggestions and references for marketing authorization holders (MAH) to conduct pharmacovigilance work. Methods Combining with the current laws and regulations, the issues existing in MAH's pharmacovigilance work in China were summed up and analyzed, and corresponding suggestions were put forward.Results The legal system of pharmacovigilance in China is becoming more and more perfect, and the information monitoring system has gradually become mature. But some MAH still don't have relevant awareness, so there is no special pharmacovigilance institution and relevant personnel.Conclusion The construction of the pharmacovigilance system still needs to be enhanced among MAH. |
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