Comparison and reflection on the policies, regulations and implementation of conditional drug approval between China and other countries/regions
10.3760/cma.j.cn114015-20230828-00638
- VernacularTitle:我国与其他国家/地区药品附条件审批政策法规及其实施情况的比较与思考
- Author:
Xinyi WANG
1
;
Jialin SUN
1
;
Xianghua QUAN
1
;
Man JIANG
1
;
Jing LI
1
Author Information
1. 青岛大学附属医院药学部，青岛 266000
- Publication Type:Journal Article
- Keywords:
Pharmacovigilance;
Drug approval;
Drug evaluation;
Prior authorization;
Drug conditional approval
- From:
Adverse Drug Reactions Journal
2024;26(1):6-11
- CountryChina
- Language:Chinese
-
Abstract:
Drug conditional approval refers to the accelerated approval and marketing of clinically urgently needed drugs with outstanding therapeutic value through the form of "approval first, verification later" before completing complete clinical trials. Since the 1990s, the United States, Canada, the European Union, Japan, Australia, and the United Kingdom have successively implemented drug conditional approval for marketing. In 2017, the application for conditional approval of drugs was implemented in China. In this paper, the pre-market conditions and requirements, post-market monitoring and supervision of drugs in China are compared with other countries/regions. Based on the comparison results, the possible optimization directions of China′s drug conditional approval system are summarized and explored.
