Comparison of system architecture between Chinese,United States,European and Japanese pharmacopoeias
10.19778/j.chp.2024.03.001
- VernacularTitle:中、美、欧、日药典体系架构的比较
- Author:
Xinyi XU
1
;
Zhen LIU
;
Leran TAO
;
Haoyun SONG
;
Dan LI
;
Wenli YU
;
Guannan WANG
;
Hao LI
;
Zhaopeng YANG
Author Information
1. 国家药典委员会,北京 100061
- Keywords:
pharmacopoeia;
general chapter;
architecture;
interoperability;
comparison
- From:
Drug Standards of China
2024;25(3):209-219
- CountryChina
- Language:Chinese
-
Abstract:
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.