FDA《新药和生物制品的获益-风险评估供企业用的指导原则》介绍

Introduction to FDA's benefit-risk assessment for new drug and biological products guidance for industry(draft)

美国食品药品管理局(FDA)于2021年9月发布了《新药和生物制品的获益-风险评估供企业用的指导原则》(草案),详细介绍了FDA目前采用的新药审评的获益-风险评估的“获益-风险框架”方法。该指导原则用最大的篇幅讨论了新药注册申请人为FDA获益-风险评估提供信息、上市前应采取的行动,也简要介绍了上市后应采取的措施。中国目前还没有类似的指导原则,详细介绍FDA该指导原则,期望对国内药品监管部门的新药和新生物制品的获益-风险评估有所启迪,特别是对药品注册申请人在新药和新生物制品全生命周期,尤其是在开发过程中,为药品监管部门提供获益-风险评估信息的行动有帮助,从而有益于加速药品审评的进程以及对申报药品做出准确审评结论。

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.