The approaches and implications of emergency drug authorization by the U.S. FDA
10.12206/j.issn.2097-2024.202309044
- VernacularTitle:美国FDA有关药品紧急授权的做法与启示
- Author:
Dan HAN
1
;
Wen GAO
1
;
Lunuan WANG
1
;
Rui SUN
2
;
Mingming GUO
1
;
Lixin SHU
1
Author Information
1. Military Medicinal Materials Support Demonstration Center, Naval Medical University, Shanghai 200433, China.
2. General Hospital of Armed Police Force, Lanzhou 730050, China.
- Publication Type:PharmacyAdministration
- Keywords:
FDA;
COVID-19;
emergency use authorization;
drug special approval
- From:
Journal of Pharmaceutical Practice and Service
2024;42(12):533-536
- CountryChina
- Language:Chinese
-
Abstract:
Objective To provide valuable insights for improving China’s special drug approval system by conducting an in-depth analysis of the practices of the U.S. Food and Drug Administration （FDA） in granting Emergency Use Authorizations （EUAs） for drugs. Methods A retrospective analysis was conducted on the FDA’s EUA decision-making process for COVID-19 therapeutics between January 2020 and June 2023. Results During the COVID-19 pandemic, the FDA adopted a series of regulatory science approaches to facilitate rapid approval of COVID-19 therapeutic drugs. The FDA granted EUA for a total of 15 COVID-19 therapeutic drugs and 4 COVID-19 vaccines, including expanded indications for marketed drugs, EUA for investigational drugs, revocation of EUA, and marketing after EUA. The main mechods for the rapid approval of EUA drugs by the FDA included the use of existing clinical trial data, omission of animal efficacy testing, merging of phase 1 and phase 2 clinical trials, and the use of clinical outcomes as surrogate endpoints, among other regulatory science methods. Conclusion The practices of the FDA in Emergency Use Authorization (EUA) of drugs, particularly its incorporation of regulatory scientific methods into the EUA process and the establishment of proactive monitoring mechanisms for drugs granted EUA, are worthy of emulation by China. It is suggested that China consider the experience of the FDA in the EUA system for drugs to further optimize and improve its special approval system for drugs.
