The development and characteristics of general notice in Chinese Pharmacopoeia 2025 Edition
10.19778/j.chp.2025.01.002
- VernacularTitle:2025年版《中国药典》凡例的变化与特点
- Author:
Fei WANG
1
;
Zonghua SONG
1
;
Shuangcheng MA
1
;
Rong SHU
1
Author Information
1. 国家药典委员会,药品监管科学全国重点实验室,北京 100061
- Publication Type:Journal Article
- Keywords:
Chinese Pharmacopoeia;
general notice;
drug standard;
quality control
- From:
Drug Standards of China
2025;26(1):11-16
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Introduce and briefly describe the status,characteristics,and writing ideas of general notice in the Chinese Pharmacopoeia 2025 edition,providing reference and suggestions for better understanding and imple-mentation of the Chinese Pharmacopoeia 2025 edition.Methods:This article elaborates on the content and revision of general notice in the Chinese Pharmacopoeia 2025 edition from the perspective of frame structure and main con-tents.Results:Compared with other pharmacopoeias of various countries,Chinese Pharmacopoeia includes stand-ards for traditional Chinese medicine,chemical drugs,biological products and excipients,pharmaceutical packa-ging materials,etc.Each section of Chinese Pharmacopoeia has its own general notice,with 34 to 48 items arranged in 11 to 12 chapters.Depending on the type of products included and the development history,the general notice in each section present differences in format and content.Given the importance and significance of the stand-ards in Chinese Pharmacopoeia,it is necessary for the industry to coordinate and unify the general notice in various parts of Chinese Pharmacopoeia.With the introduction and revision of regulations,changes in the content of phar-macopoeias,and the application of new technologies,methods,and concepts in drug quality control,considering the unique characteristics of various drugs in quality control and supervision,Chinese Pharmacopoeia has compre-hensively standardized relevant requirements.While taking into account the characteristics of the first,second,third,and fourth parts of the pharmacopoeia,it retains the characteristics of relative uniformity and the content of each part,achieving the unified standardization of the general rules of each general notice in the Chinese Pharmaco-poeia 2025 edition and the coordination and consistency of common content.Conclusion:The current version of Chinese Pharmacopoeia has undergone significant changes and improvements in both form and content.By introdu-cing the overall situation and revised content of general notice in the Chinese Pharmacopoeia 2025 edition,pharma-copoeia users can have a deeper understanding of Chinese Pharmacopoeia and use it correctly.
