中药、天然药物学研究资料综述撰写格式与要求技术指导原则.doc

（第二稿草稿）二OO?五年三月2目录一、概述···································································································································?1二、撰写格式和要求·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?·?1（一）中药、天然药物新药申请····················································································?11、申请临床研究····································································································?11.1?主要研究结果综述·····································································································?11.1.1?剂型选择及规格的确定依据················································································?11.1.2?制备工艺及研究内容························································································?11.1.3?质量研究及质量标准····························································································?21.1.4?初步稳定性考察········································································································?31.2?分析与评价······························································································?32、申请生产···························································································································?42.1?主要研究结果综述·········································································································?42.1.1?临床批件情况············································································································?42.1.2?生产工艺·····················································································································?42.1.3?质量研究及质量标准······························································································?42.1.4?稳定性考察·················································································································?42.1.5?说明书、包装、标签···························································