关键词: font-size:medium, ">风险评估与减轻策略；NDA；BLA；REMS药房门户网站

Abstract: Objective：To learn from the risk evaluation and mitigation strategy in the United States， and to provide reference for establishing a good drug risk control system in China. Methods： the risk evaluation and mitigation strategy in the United States was summarized， its implementation status was analyzed and learned the practical experience of the REMS pharmacy portal to provide enlightenment of relevant mechanism in China. Results & Conclusion： The practice of US risk assessment and corrective strategies always adheres to the principle of “ensuring that a drug′s benefits outweigh its risks”， which minimizes the risk of patients using drugs， improve the transparency of drug information， and reduce and prevent the occurrence of adverse drug reactions after marketing， and improve the life cycle monitoring of drugs. Through the experience of the United States， based on the status of China′s medical and health system， we can explore the establishment of a medical linkage network that meets the development requirements.

Key words: font-size:medium, ">Risk evaluation and mitigation strategy； NDA； BLA； REMS pharmacy portal