美国食品药品管理局（FDA）于2015年12月发布了“IND安全性报告的安全性评估指导原则（草案）”，包括前言、背景、安全评估组织结构、安全性评估实践、前瞻性计划等5个部分。该指导原则为按新药临床研究（IND）开发的人用药物和生物制品IND安全性报告的系统方法提供指导，对IND安全性报告的安全性评估从程序、组织架构、具体操作等方面提供了较为详细的描述。我国目前尚无这类指导原则，了解该指导原则对于新药研究者对临床试验严重不良事件和不良反应的评估和判断有所帮助，简介其主要内容。

FDA issued "Safety Assessment for IND Safety Reporting Guidance for Industry(Draft)" in December 2015, including introduction, background, safety assessment organization structure, safety assessment practices, and prospective planning. The document provides guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND, and describes the procedure, organization structure, and practices for safety assessment of IND safety reporting in details. However, there is no similar guidance in China at present. Understanding the guidance are helpful for assessment and judgement of adverse events and adverse reaction in clinical trial, therefore the main content is introduced.