风险评估和缓解策略（REMS）是一种必要的风险管理策略，可以包括一个或多个要素，以确保药物的获益超过风险。美国食品药品监督管理局（FDA）于2024年5月发布了“REMS逻辑模型：链接方案设计与评估框架”的供企业用的指导原则草案。该指导原则提供了一种系统、结构化的REMS设计、实施和评估方法。该指导原则详细描述了REMS逻辑模型在REMS生命周期的3个阶段（设计、实施和评估）的具体做法，包括设计阶段情况背景的评估和REMS目标的建立；实施阶段REMS的输入、活动和输出的开发；评估阶段对短期和长期结果以及影响的评估。我国目前还没有类似的指导原则。详细介绍FDA该指导原则，期待对我国这方面的研究和监管有益。

A risk assessment and mitigation strategy (REMS) is a required risk management strategy that can include one or more elements to ensure that the benefits of a drug outweigh its risks. The FDA issued the “REMS Logic Model: A Framework to Link Program Design with Assessment Draft Guidance for Industry” in May 2024. This guidance provides a systematic, structured approach to the design, implementation, and evaluation of the REMS. This guidance provides a detailed description of the specific approach of the REMS logic model in the three phases of a REMS life cycle (design, implementation, and evaluation), including assessing the situation context and establishing a goal for the REMS during the design phase， developing the inputs, activities, and outputs of the REMS during the implementation phase as well as evaluating the short-and long-term outcomes and impact during the evaluation phase. There is currently no similar guidance in our country. Detailed introduction of the FDA's guidance is expected to be beneficial for research and regulation in this area in China.

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