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为科学合理地评价“已有国家标准药品减免临床试验的改剂型和仿制品种”的有效性和安全性,国家食品药品监督管理局最近制定了《中药工艺相关问题的处理原则》、《含毒性药材及其他安全性问题中药品种的处理原则》、《中药改剂型品种剂型
In order to scientifically and reasonably evaluate the effectiveness and safety of “reforms and imitation products” of existing national standards for drug exemption clinical trials, the State Food and Drug Administration has recently formulated the “Principles for Handling Problems Related to Chinese Medicine Technology” and " Principles for Treatment of Chinese Medicinal Herbs Containing Toxic Medicinal Materials and Other Safety Issues, and “Different Dosage Forms for Modified Chinese Medicinal Formulas”