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文章旨在了解欧盟药物警戒检查制度的背景与实施,为我国开展检查工作提供借鉴和参考。根据欧盟法规,欧洲药品管理局建立了一套包括检查程序、检查内容在内的完整体系。建立检查制度对于监督和促进生产企业开展药品不良反应报告和监测工作具有重要作用,我国《药品不良反应报告和监测管理办法》已为此奠定了实施基础,但尚缺乏具体实施的程序与规范,值得今后深入研究和实践。
The purpose of this article is to understand the background and implementation of the EU drug inspection system and to provide reference for China’s inspection work. According to the EU regulations, the European Medicines Agency has established a complete system that includes inspection procedures and inspection contents. The establishment of the inspection system plays an important role in monitoring and promoting the reporting and monitoring of adverse drug reactions in manufacturing enterprises. The Measures for the Management and Reporting of Adverse Drug Reaction Reporting in our country have laid the foundation for its implementation. However, there are still a lack of specific procedures and norms for implementation, Worth further research and practice in the future.