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在当前药品监管对象多、涉药单位情况复杂、市场涉药主体良莠不齐的情况下,为实现对药品生产、流通、使用环节的全面、有效监管,部分地区的药品监管部门已经将远程监控作为一种有效的行政监管辅助手段加以运用。本文以我国药品远程电子监管的现状为背景,阐述实施远程监控的现实意义,并以目前技术条件下较为可行的药品远程监控手段为例,以药品质量中间控制环节的药品流通领域为实施对象,分析远程监控应用相对于药品监管部门产生的效益与风险,以期探索出一种更高效率、更小风险的药品远程监控模式。
Under the circumstances that there are many current drug regulatory targets, the situation of the involved pharmacies is complex, and the main market involved in the drug is mixed, in order to realize the comprehensive and effective supervision over the production, distribution and use of pharmaceutical products, the drug regulatory authorities in some regions have already taken remote monitoring as one Effective administrative supervision tools to be used. In this paper, based on the status quo of remote electronic supervision of pharmaceuticals in China, this paper expounds the practical significance of implementing remote monitoring. Taking the more feasible drug monitoring methods under current technical conditions as an example, the article takes the field of drug circulation in the intermediate control of pharmaceutical quality as the object of implementation, Analyze the benefits and risks of remote monitoring applications relative to drug regulatory authorities in order to explore a more efficient and less risk remote drug monitoring model.