Toxicology studies for compound preparations of traditional Chinese medicine in ancient classic prescriptions

• Published in: Zhongguo zhongyao zazhi Vol. 47; no. 23; p. 6529
• Main Authors: Huang, Fang-Hua, Wang, Qing-Li
• Format: Journal Article
• Language: Chinese
• Published: China 01-12-2022
• Subjects: Drug Prescriptions; Drugs, Chinese Herbal - toxicity; Medicine, Chinese Traditional; Prescriptions; toxicology studies; traditional Chinese medicine(TCM); compound preparations of traditional Chinese medicine in ancient classic prescriptions
• ISSN: 1001-5302
• DOI: 10.19540/j.cnki.cjcmm.20221025.601

According to Provisions for Drug Registration and Categories and Requirements of Application Dossiers for Traditional Chinese Medicine(TCM), non-clinical safety research/toxicology research should be conducted for classical compound Chinese medicine prescriptions(Categories 3.1 and 3.2), and the data should be submitted at the application for the marketing authorization. Based on the requirements of toxicology research in Categories and Requirements of Application Dossiers for Traditional Chinese Medicine, this study further refined and clarified the requirements of toxicology research on classical compound Chinese medicine preparations(Categories 3.1 and 3.2).