Evolution, current situation and reflections of biological reference materials' technical guidelines and management regulations in WHO and in China
10.13200/j.cnki.cjb.004485
- VernacularTitle:WHO和我国生物标准物质技术指南及管理规程的沿革、现状和思考
- Author:
WANG Yiping
- Publication Type:Journal Article
- Keywords:
Biological product;
Reference material;
International standard(IS);
International referenceregent(IRR);
National biological standard;
National biological reference
- From:
Chinese Journal of Biologicals
2025;38(05):630-635
- CountryChina
- Language:Chinese
-
Abstract:
Reference material is a kind of criteria“ruler”for the quality control and evaluation of biological products. WorldHealth Organization(WHO) technical reports and guidelines, China's management regulations about biological referencematerials and Chinese Pharmacopoeia play an important guiding role in the development,distribution and use of standards. Inorder to meet the needs of the development of the biological product industry, WHO guidelines and Chinese national manage-ment regulations about biological reference materials have been revised for several times. This paper summarizes the evolu-tion and current situation of the definition, classification and technical requirements for WHO international biological stan-dards and national biological standards in China, aiming to further improve the preparation and application of national biologi-cal reference materials in China.
