Introduction on the revised content on abnormal toxicity test in the Chinese Pharmacopoeia 2025 Edition(Volume Ⅲ)
10.19778/j.chp.2025.01.015
- VernacularTitle:2025年版《中国药典》三部关于异常毒性检查修订内容的解读
- Author:
WANG Xiaojuan
;
WANG Liping
;
LIU Ying
;
LI Huiyi
- Publication Type:Journal Article
- Keywords:
abnormal toxicity test;
Chinese Pharmacopoeia;
biological products;
introduction
- From:
Drug Standards of China
2025;26(1):105-109
- CountryChina
- Language:Chinese
-
Abstract:
Based on the implementation of GMP, comprehensive improvement of quality control measures, and consideration of the 3Rs principle for experimental animals, Several years ago, WHO, the European Pharmacopoeia and the FDA gradually abolished the testing for abnormal toxicity of biological products, and the Chinese Pharmacopoeia 2025 Edition(Volume Ⅲ)also revised the testing for abnormal toxicity of biological products. In order to help users of the Chinese Pharmacopoeia(Volume Ⅲ) better understand and implement this pharmacopoeia, this article provides a detailed review of the changes in regulatory concepts for abnormal toxicity test in various countries and the process of gradually phasing out abnormal toxicity test, as well as the actual situation of China’s pharmaceutical industry. It also interprets the ideas and considerations for revising the Chinese Pharmacopoeia 2025 Edition(Volume Ⅲ) on abnormal toxicity test for biological products.
- Full text:20250311143709641020250215.pdf
