Comparison of Domestic and International Regulations on Blood Products and Insights
10.3870/j.issn.1004-0781.2025.08.010
- VernacularTitle:血液制品国内外监管法规比较与启示
- Author:
Hongbo PAN
1
;
Yingying LIU
;
Pei MAO
;
Michael WENDT
;
Wei ZHANG
;
Zhihua YUE
;
Zhigang ZHAO
Author Information
1. CSL Behring China(杰特贝林中国),北京 100738
- Publication Type:Journal Article
- Keywords:
Blood products;
Regulatory models;
Comparison of regulations
- From:
Herald of Medicine
2025;44(8):1250-1256
- CountryChina
- Language:Chinese
-
Abstract:
The blood products industry in China,the United States,the European Union and Japan are at different stages of development,with very different laws,regulations and regulatory systems.This paper uses methods such as literature review,policy comparison,and case study.By analyzing and comparing the blood product regulatory policies in various countries,it is found that compared with the United States,the European Union and Japan,China has differences in several areas,including plasma quarantine period,plasma fractionation processes and intermediate products,segmented production of blood products,and import management policies.It is suggested that we should learn from foreign regulatory experiences,and explore the establishment of blood product regulatory policies suitable for China's national conditions.Recommendations include optimizing China's source plasma quarantine period and blood product production process management policies,promoting multiple sites and segmented production of blood products,and establishing flexible blood product import and export management systems.These measures aim to provide references for promoting the development of the blood product industry and improving the accessibility of medications for the public.
