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监管科学创新是药品监管工作质量提升、 效率提高的重要推动力. 以品种为主线, 探索药品生命周期不同环节的安全信息和风险管控, 将品种监管和体系监管相融合, 建立品种档案, 是进行监管科学创新的一个探索方向. 本文从生物制品监管角度, 论述了监管信息管理系统的设计和开发的思路, 并讨论了该信息管理系统需要思考的问题以及推广的前景.“,”Regulatory science innovation is an important driving force to improve the quality and efficiency of drug regulation affairs. Exploring safety information and risk control in different links of drug life cycle with variety as the main line, integrating variety regulation and system regulation and establishing variety archives are the direction of scientific innovation in drug regulation. From the point of biological product regulation, this paper discussed the design and development of the regulatory information management system, and discussed the problems that need to be considered and the prospects for its popularization.