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| 《药品管理法》中药物警戒制度实施的思考 |
| Consideration on the implementation of pharmacovigilance system in Drug Administration Act |
| 投稿时间：2019-10-10 修订日期：2019-10-22 |
| DOI： |
| 中文关键词: 药物警戒 个例安全报告 不良反应 数据库 |
| 英文关键词: pharmacovigilance ICSR adverse reactions database |
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| 中文摘要: |
| 摘要目的：新颁布的《中华人民共和国药品管理法》首次引入建立药物警戒制度，原有的不良反应监测和报告制度已不能满足我国药品监管的要求，需要从法规层面和实际操作层面整体设计。方法：通过查阅国内外文献，WHO、FDA和EMA网站等，比较分析WHO、美国和欧盟的药物警戒制度。结果与结论：对比WHO、美国和欧盟的药物警戒制度发现，我国的药物警戒制度处在刚刚起步阶段，本文从法律法规框架方面、科学监管体系方面、建立专业数据库方面以及加强药品上市许可持有人报告等方面提出了建议和意见。 |
| 英文摘要: |
| AbstractObjective: The Drug Administration Law of the PRC（2019 ）for the first time that China should establish a pharmacovigilance system. However, the current adverse reaction monitoring and reporting system in China cannot meet the requirements of China"s drug supervision, which requires an overall design from the level of regulation and practical operation.Methods:Using literature analysis,compared the pharmacovigilance systems of WHO, the United States and the European Union and check out WHO, FDA and EMA websites.Results and Conclusion: By comparing the pharmacovigilance systems of WHO, the United States and the European Union, it is found that China"s pharmacovigilance system is still in its infancy. This reserch puts forward suggestions and opinions from the aspects of legal and regulatory framework, scientific regulatory system, establishment of professional database, and strengthening the report of MAHs. |
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