Historical Evolution,Contradiction Analysis and Policy Recommendations of China's Laws and Regulations on Blood Products Import
10.3870/j.issn.1004-0781.2025.08.008
- VernacularTitle:中国血液制品进口法律法规的历史沿革和矛盾分析及政策建议
- Author:
Luofei ZHANG
1
;
Zishun TIAN
;
Ziyi WANG
;
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):1242-1246
- CountryChina
- Language:Chinese
-
Abstract:
The legal and regulatory system for the import of blood products in China has undergone a three-stage evolution of"safety first,demand-driven and standard upgrading",ultimately forming a dual control framework that centers on infectious disease prevention and control as well as quality approval.While the current policy effectively ensures biosafety,it also faces several deep-seated contradictions.These include the worsening imbalance between supply and demand,limited access to clinically needed blood products,and insufficient alignment with international standards.Moreover,strict regulation has also constrained technological innovation and market diversification.To address these challenges,it is suggested to establish a synergy mechanism that integrates a"clinical urgent need list,"hierarchical supervision,and mutual recognition of Good Manufacturing Practice(GMP).By implementing dynamic access,risk classification management,and international certification mutual recognition,it is possible to achieve compatible development between the safety baseline and medical accessibility.
