中医药
授权
药方
医学
传统医学
替代医学
药理学
计算机科学
计算机安全
病理
作者
Fengtao Huang,Qingli Wang
出处
期刊:PubMed
日期:2022-12-01
卷期号:47 (23): 6529-6532
标识
DOI:10.19540/j.cnki.cjcmm.20221025.601
摘要
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).
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