Regulatory Barriers and Optimization Strategies for the Import of Blood Products in China
10.3870/j.issn.1004-0781.2025.08.009
- VernacularTitle:中国血液制品进口法规壁垒及优化策略建议
- Author:
Zishun TIAN
1
;
Luofei ZHANG
;
Wei ZHANG
;
Jiping HUO
;
Zhigang ZHAO
Author Information
1. 首都医科大学附属北京天坛医院药学部,北京 100070;首都医科大学药学院临床药学系,北京 100069
- Publication Type:Journal Article
- Keywords:
Blood products;
Law;
Regulations;
Import
- From:
Herald of Medicine
2025;44(8):1247-1250
- CountryChina
- Language:Chinese
-
Abstract:
Blood products play a pivotal role in modern medical treatment and healthcare system,and the clinical demand in China continues to grow.However,there is a significant supply gap for raw plasma domestically,with over 60％of human albumin relying on imports.The regulatory framework for imported blood products in China has undergone multiple rounds of adjustments,establishing a comprehensive lifecycle oversight system centered around the《Law of the People's Republic of China on the Administration of Drugs》and the《Measures for the Administration of Batch Release of Biological Products》.While ensuring safety,this framework has also led to issues such as insufficient clinical supply and elevated corporate costs because of stringent market access requirements,complex approval procedures,and tariff barriers.Specifically,import market access barriers have imposed a'dual-certification'burden,and tariff barriers have increased the costs of some products,exacerbating the financial burden on patients.In response to these challenges,it is recommended to establish an interdepartmental information-sharing platform,promote mutual recognition of international quality standards,form a rapid approval team for urgently needed medications,and reduce or exempt tariffs for clinically critical products.
