Comparison of interoperability among the standard systems of Chinese,the United States,European,and Japanese Pharmacopoeias and other standard systems
10.12173/j.issn.1008-049X.202401151
- VernacularTitle:中、美、欧、日药典标准体系与其他标准体系互操作性的比较研究
- Author:
Xinyi XU
1
;
Zhen LIU
;
Leran TAO
;
Haoyun SONG
;
Dan LI
;
Wenli YU
;
Guannan WANG
;
Heng LI
;
Yun WANG
;
Zhaopeng YANG
Author Information
1. 国家药典委员会(北京 100061)
- Keywords:
Pharmacopoeia;
System;
Standard;
Interoperability;
Comparison
- From:
China Pharmacist
2024;27(2):233-241
- CountryChina
- Language:Chinese
-
Abstract:
Objective To provide reference for the optimization and improvement of interoperability between the standard system of the Chinese Pharmacopoeia and other standards.Methods The interoperability of various pharmacopoeia standard systems was compared by searching for citations from the Chinese Pharmacopoeia,the United States Pharmacopoeia-National Formulary,the European Pharmacopoeia,the Japanese Pharmacopoeia,and other standards,including references to domestic regulations and guidelines,standards of the International Organization for Standardization,guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use,documents of the World Health Organization,and standards from other countries and international organizations.Results In recent years,pharmacopoeias in the world had continuously increased the citation of non pharmacopoeial standards.The types,quantities,and fields of the United States Pharmacopoeia-National Formulary referencing other standards far exceed those of other pharmacopoeias.The Chinese Pharmacopoeia cites the least number of other standards.Conclusion It is suggested that the Chinese Pharmacopoeia should enhance the interoperability with other standard systems in the standards of various professional fields,enhance the openness,harmonization and advantages,and form a more complete standard system.
