Objective: To provide reference and solution for approving new drugs and reserves for the biodefence in tackling major public health emergencies. Methods: Combine with the approval instance, the article summarizes the main content, application scope and implementation status of U.S. FDA "animal rule", and discusses the drug approval mechanism in the United States and China in response to major public health emergencies. Results and Conclusions: In drug research and development for possible bioterrorism attacks and major epidemics, the evaluation scale could be different from that of common drugs, a strategic reserve of drugs for the bio-defence should be established to provide systematic support for responding to major public health emergencies.
Wang Boyang, Gao Jin, Wang Zidong, Li Jie.
Application and Implications of U.S. FDA “Animal Rule” in the Biodefence Drug Development[J]. Chinese Pharmaceutical Affairs, 2020, 34(6): 636-643 https://doi.org/10.16153/j.1002-7777.2020.06.004
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