美國食品藥品管理局（FDA）于2015年12月發(fā)布了“IND安全性報(bào)告的安全性評估指導(dǎo)原則（草案）”，包括前言、背景、安全評估組織結(jié)構(gòu)、安全性評估實(shí)踐、前瞻性計(jì)劃等5個(gè)部分。該指導(dǎo)原則為按新藥臨床研究（IND）開發(fā)的人用藥物和生物制品IND安全性報(bào)告的系統(tǒng)方法提供指導(dǎo)，對IND安全性報(bào)告的安全性評估從程序、組織架構(gòu)、具體操作等方面提供了較為詳細(xì)的描述。我國目前尚無這類指導(dǎo)原則，了解該指導(dǎo)原則對于新藥研究者對臨床試驗(yàn)嚴(yán)重不良事件和不良反應(yīng)的評估和判斷有所幫助，簡介其主要內(nèi)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.