Comparative study on pharmaceutical emergency approval systems in China and other countries
10.12206/j.issn.2097-2024.202310015
- VernacularTitle:中外药品应急审批制度对比研究
- Author:
Lijun CUI
1
;
Yanting CHEN
1
;
Yonghe FEI
1
;
Jing CHEN
1
Author Information
1. Department of Military Medical Supply Administration, School of Pharmacy, Naval Medical University, Shanghai 200433, China.
- Publication Type:PharmacyAdministration
- Keywords:
drugs;
emergency approval;
institutional comparison;
emergency authorization
- From:
Journal of Pharmaceutical Practice and Service
2024;42(8):359-364
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the ideas and measures to further optimize China’s drug emergency approval system by comparing the drug emergency approval systems in China and other countries. Methods The current situation of China’s drug emergency approval system was analyzed and compared with the relevant systems of the United States, the European Union and Japan. Results The goal of drug emergency approval in other countries is clearly positioned to accelerate the review and listing of urgently needed clinical drugs for the purpose of clinical needs, forming a multi-channel, multi-mode and multi-mechanism priority review system covering the whole process, and the regulatory system is clear, complete, and operable. The corresponding approval system in China started late and is in the stage of continuous improvement, which needs to be improved in terms of system construction, government functions, personnel optimization, and post-market supervision. Conclusion Drug regulatory authorities in China should summarize their past work experience and draw on some feasible approval models and regulatory approaches in foreign countries, further improve the system and process of the drug emergency approval system and enhance the efficiency of drug approval and the ability to protect drugs in response to emergencies.
