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根据药械安全监测档案管理工作的要求,结合药品监管档案管理办法及管理工作的实践,针对目前药械安全性监测档案管理工作中存在的问题提出对策与措施,促使药械安全性监测档案能够及时完整的归档,以保证药品和医疗器械监管工作中的查阅利用。药械安全性监测档案管理工作是药械安全性监测工作中的一个重要组成部分,同时也是为行政监管部门实现科学监管的有力技术支撑[1]。本文结合
According to the requirements of file management of drug safety monitoring files and the practice of file management methods and management of drug monitoring files, countermeasures and measures are put forward to solve the problems existing in the current file management of drug safety monitoring, which prompts the files of drug safety monitoring files to be timely and complete Archiving, in order to ensure the access of medicines and medical devices in the regulatory work. Pharmacological safety monitoring file management work is an important part of drug safety monitoring work, but also for the administrative regulatory departments to achieve a strong technical support for scientific regulation [1]. This article combined