風(fēng)險評估和緩解策略（REMS）是一種必要的風(fēng)險管理策略，可以包括一個或多個要素，以確保藥物的獲益超過風(fēng)險。美國食品藥品監(jiān)督管理局（FDA）于2024年5月發(fā)布了“REMS邏輯模型：鏈接方案設(shè)計與評估框架”的供企業(yè)用的指導(dǎo)原則草案。該指導(dǎo)原則提供了一種系統(tǒng)、結(jié)構(gòu)化的REMS設(shè)計、實施和評估方法。該指導(dǎo)原則詳細(xì)描述了REMS邏輯模型在REMS生命周期的3個階段（設(shè)計、實施和評估）的具體做法，包括設(shè)計階段情況背景的評估和REMS目標(biāo)的建立；實施階段REMS的輸入、活動和輸出的開發(fā)；評估階段對短期和長期結(jié)果以及影響的評估。我國目前還沒有類似的指導(dǎo)原則。詳細(xì)介紹FDA該指導(dǎo)原則，期待對我國這方面的研究和監(jiān)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 The FDA issued the “REMS Logic Model: A Framework to Link Program Design with Assessment Draft Guidance for Industry” in May 2024.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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