美國食品藥品管理局（FDA）于2021年9月發(fā)布了《新藥和生物制品的獲益-風(fēng)險(xiǎn)評(píng)估供企業(yè)用的指導(dǎo)原則》（草案），詳細(xì)介紹了FDA目前采用的新藥審評(píng)的獲益-風(fēng)險(xiǎn)評(píng)估的"獲益-風(fēng)險(xiǎn)框架"方法。該指導(dǎo)原則用最大的篇幅討論了新藥注冊(cè)申請(qǐng)人為FDA獲益-風(fēng)險(xiǎn)評(píng)估提供信息、上市前應(yīng)采取的行動(dòng)，也簡(jiǎn)要介紹了上市后應(yīng)采取的措施。中國目前還沒有類似的指導(dǎo)原則，詳細(xì)介紹FDA該指導(dǎo)原則，期望對(duì)國內(nèi)藥品監(jiān)管部門的新藥和新生物制品的獲益-風(fēng)險(xiǎn)評(píng)估有所啟迪，特別是對(duì)藥品注冊(cè)申請(qǐng)人在新藥和新生物制品全生命周期，尤其是在開發(fā)過程中，為藥品監(jiān)管部門提供獲益-風(fēng)險(xiǎn)評(píng)估信息的行動(dòng)有幫助，從而有益于加速藥品審評(píng)的進(jìn)程以及對(duì)申報(bào)藥品做出準(zhǔn)確審評(píng)結(jié)論。

FDA issued benefit-risk assessment for new drug and biological products guidance for industry (draft) in September 2021. The guidance details the Benefit-Risk Framework approach for benefit-risk assessment of new drug review currently adopted by FDA. The guidance discuss the activities that new drug registration sponsors should take in premarket in order to provide information for FDA benefit-risk assessment, and also briefly introduce the measures that should be taken in postmarket. At present, there is no similar guidance in China. This paper introduces the guidance of FDA in detail, hoping to enlighten the benefit-risk assessment of new drugs and biological products by China's drug regulatory authorities, especially for the activities of drug registration sponsors to provide benefit-risk assessment information for drug regulatory authorities in the whole life cycle of new drugs and biological products, especially in the development process. Thus, it is beneficial to accelerate the process of drug review and make accurate review conclusions for the declared drugs.

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