Analysis of emergency Drug Approval System in China and the United States under Public Health emergencies and its enlightenment to China

  • Wei Chen
  • Yi Liang

Abstract

Objective: Public health emergencies, such as COVID-19, put forward a severe test to the response system of countries all over the world, including China. Especially under such conditions, the establishment and operation of the emergency drug approval system is particularly important. The purpose of this paper is to compare and analyze the emergency drug approval system between China and the United States, and learn from the experience of developed countries to improve China's drug review capability in response to public health emergencies.


This paper mainly analyzes the emergency drug approval system of China and the United States under public health emergencies through literature research and comparative analysis theory. Although there are four channels to accelerate the approval of drugs for listing in China, none of them can solve the problem of emergency drug use in the face of public health emergencies, and cannot become the policy basis for the use of unlisted drugs or drugs beyond the instructions.


Conclusion: On the basis of maintaining China's own institutional advantages and drawing on foreign experience, this paper puts forward relevant policy recommendations to improve China's emergency drug approval system in the event of public health emergencies.

Keywords: Public health emergencies, Emergency drugs, COVID-19, National Medical Products Administration(NMPA), Emergency Use Authorization (EUA), Department of Health and Human Services(HHS), Priority Review Voucher (PRV), FDA

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How to Cite
Chen, W., and Y. Liang. “Analysis of Emergency Drug Approval System in China and the United States under Public Health Emergencies and Its Enlightenment to China”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 4, Dec. 2022, pp. 53-61, doi:10.22270/ijdra.v10i4.564.