中药、天然药物临床研究资料综述撰写格式和要求技术指导原则(2)

1.1.1 人体耐受性试验概要 ··············································································· 4

1.1.2 临床药理学试验概要 ··············································································· 4

1.2 Ⅱ期临床试验概要····························································································· 5

1.3 Ⅲ期临床试验概要····························································································· 5

2. 分析与评价·························································································· 7

三． 参考文献······················································································································· 8

四． 著 者······················································································································· 8 附： 《中药、天然药物临床研究资料综述格式和要求》技术指导原则

起草说明···················································································································· 9

中药、天然药物临床研究资料综述撰写格式和要求技术指导原则

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。

本指导原则旨在通过对中药、天然药物临床研究资料综述的格式和内容等方面的要求，进一步规范申报资料，并加强药品注册申请人对新药研发过程及结果的分析和自我评价。

本指导原则提供了不同注册类别可能涉及的内容，药物研究人员需按照《药品注册管理办法》中对不同注册申请类别的要求，结合中药、天然药物的不同特点及具体品种特点，合理取舍，确定各自所需要提供的资料和临床研究内容,把握重点，在此基础上，科学、客观、规范地撰写临床研究资料综述。要求文字简炼，逻辑合理，重点突出。

本指导原则按照申请临床研究、申请生产两个阶段分别进行阐述。 具体内容包括主要结果、分析与评价两部分。

二、撰写格式和要求

（一） 申请临床研究

本部分内容为支持进入临床研究的所有与临床有关的理论与试验研究资料的简要介绍。应注意围绕适应病症，对处方合理性、创新性及临床研究的科学性、可行性进行简明扼要的论述。

1.