1.Comparison of system architecture between Chinese,United States,European and Japanese pharmacopoeias
Xinyi XU ; Zhen LIU ; Leran TAO ; Haoyun SONG ; Dan LI ; Wenli YU ; Guannan WANG ; Hao LI ; Zhaopeng YANG
Drug Standards of China 2024;25(3):209-219
The standard system refers to the scientific organic whole formed by the internal connections of stand-ards within a certain range.The completeness of the drug standard system plays a crucial role in ensuring drug safety.Pharmacopoeia is the core of the drug standard system.This article compared the architecture of the Chi-nese Pharmacopoeia,the United States Pharmacopoeia,the European Pharmacopoeia,and the Japanese Pharma-copoeia on the aspects of overall architecture,monographs architecture,general notice architecture,general tech-nical requirements architecture,and other standard architecture,as well as the implementation of various types of standards,aiming to provide reference for the optimization and improvement of the standard system of the Chinese Pharmacopoeia.
2.Comparison of interoperability among the standard systems of Chinese,the United States,European,and Japanese Pharmacopoeias and other standard systems
Xinyi XU ; Zhen LIU ; Leran TAO ; Haoyun SONG ; Dan LI ; Wenli YU ; Guannan WANG ; Heng LI ; Yun WANG ; Zhaopeng YANG
China Pharmacist 2024;27(2):233-241
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.