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:
ZHANG Jun
;
NING Baoming
;
WEI Shifeng
;
SHEN Haoyu
;
SHANG Yue
;
ZHU Ran
;
XU Xinyi
;
CHEN Lei
;
LIU Tingting
;
MA Shuangcheng
- Publication Type:Journal Article
- Keywords:
Chinese Pharmacopoeia 2025 Edition volume Ⅳ;
general chapters;
revisions and amendments
- From:
Drug Standards of China
2025;26(1):034-044
- 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, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily 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 environmental-friendly； replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug 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.
- Full text:202503111349185401120250206.pdf
