Implementation of US FDA's Drug Risk Evaluation and Mitigation Strategies

doi:10.19803/j.1672-8629.2020.12.05

Abstract

Abstract: Objective To analyze the current implementation and operation methods of the US FDA’s Risk Evaluation and Mitigation Strategies (REMS), and to provide reference for the implementation of the drug risk management plan specified in the Drug Administration Law of China.Methods Chinese and foreign literature and the FDA-approved REMS were reviewed, and the single system and shared system for implementation of REMS that had been approved and revoked were analyzed.Results As a risk management plan, REMS is a dynamic risk management tool. Not all drugs require REMS. The principle of prioritizing the use of risk minimization tools should be from simple to complex, from easy to difficult. Regardless of the risk management tool adopted, the risk management plan has to intervene with doctors and patients directly.Conclusion China should explore ways to execute the risk management plan specified by the Drug Administration Law, establish an adaptive method of implementing the drug risk management plan and formulate supporting documents in order to control drug risks dynamically.

Key words: risk evaluation and mitigation strategies, drug, risk, FDA, risk management tools

CLC Number:

WEI Fuqian, ZHANG Wei, YANG Yue. Implementation of US FDA's Drug Risk Evaluation and Mitigation Strategies[J]. Chinese Journal of Pharmacovigilance, 2020, 17(12): 871-876.

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