Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
10.19778/j.chp.2025.01.006
- VernacularTitle:2025年版《中国药典》(四部)通用技术要求和指导原则增修订概况
- Author:
Jun ZHANG
1
;
Baoming NING
;
Shifeng WEI
;
Haoyu SHEN
;
Yue SHANG
;
Ran ZHU
;
Xinyi XU
;
Lei CHEN
;
Tingting LIU
;
Shuangcheng MA
Author Information
1. 国家药典委员会,北京 100061
- Publication Type:Journal Article
- Keywords:
Chinese Pharmacopoeia 2025 Edition volume Ⅳ;
general chapters;
revisions and amendments
- From:
Drug Standards of China
2025;26(1):34-44
- CountryChina
- Language:Chinese
-
Abstract:
To introduce the general thinking,guidelines,work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition,and to summarize and figure out the main characteristics on dosage forms,physico-chemical testing,microbial and biological testing,ref-erence standards and guidelines.The newly revised general chapters of pharmacopoeia give full play to the norma-tive and guiding role of the Chinese Pharmacopoeia standard,track the frontier dynamics of international drug regu-latory science and the elaboration of monographs,expand the application of state-of-the-art technologies,and stead-ily promote the harmonization and unification with the ICH guidelines;further enhance the overall capacity of TCM quality control,actively implement the 3 R principles on animal experiments,and practice the concept of environ-mental-friendly;replace and/orreduce the use of toxic and hazardousreagents,strengthen the requirementsofdrug safety control.This paper aims to provide a full-view perspective for the comprehensive,correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
