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中药新药研制步骤、审批程序和有关要求吕靖中,杜廷海河南中医学院第一附属医院(450000)主题词中成药/分类,研究设计,@审批《新药审批办法─—有关中药部分的修订与补充规定》(以下简称《补充规定》)颁布后,对中药新药的研制提出了更高的要求。作为研制工...
Development steps, approval procedures and related requirements of new Chinese medicines Lu Jingzhong, Du Tinghai First Affiliated Hospital of Henan College of Traditional Chinese Medicine (450000) Chinese medicines/classifications, research and design, and approval of “Approval Methods for New Drugs—Revisions and Supplementary Provisions on Chinese Medicines” (Hereinafter referred to as “Supplementary Provisions”) has issued higher requirements for the development of new Chinese medicines. As a developer...