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（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······································1
1、申请临床研
究··············································1
1.1 主要研究结果综
述··············································
1
1.1.1 剂型选择及规格的确定依
据····································1
1.1.2 制备工艺及研究内
容·········································1
1.1.3 质量研究及质量标
准··········································2
1.1.4 初步稳定性考
察·············································
·3
1.2 分析与评
价···········································3
2、申请生
产················································
·········4
2.1 主要研究结果综
述··············································
·4
2.1.1 临床批件情
况·················································
··4
2.1.2 生产工
艺··············································
······4
2.1.3 质量研究及质量标
准············································4
2.1.4 稳定性考
察··············································
·····4
2.1.5 说明书、包装、标
签···········································4
2.2 分析与评
价···········································4
（二）已有国家标准的中成药和天然药物制剂的申
请··················5
1、主要研究结果综
述················································
··5
1.1 生产工
艺···········································5
1.2 质量研究及质量标
准···········································5
1.3 稳定性考
察··············································
·····5
1.4 说明书、包装、标
签···········································5
3
2、分析与评
价···········································5
三、参考文
献··············································
········5
四、著
者··············································
············6
附：《中药、天然药物药学研究资料综述撰写格式和要求》
技术指导原则的起草说
明··········································7
4
一、概述
本指导原则是根据《药品注册管理办法》的有关要求，结合我国中药、天然药物研发的实际情况而制订。
本指导原则的制订旨在指导注册申请人规范对药学研究综述资料的撰
写，引导注册申请人对药学研究结果及药学与药理毒理、临床等相关研究之间的相互联系进行分析与评价，关注药品研究的整体性、系统性和科学性，从而提高药品研究开发的水平。
药学研究包括原料的鉴定与前处理、剂型选择、制备工艺研究、中试研
究、质量研究和质量标准的制订、稳定性研究（包括直接接触药品的包装材
料或容器的研究）
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