FDA“治疗等效性评价供企业用指导原则”(草案)介绍

Introduction to FDA’s"Evaluation of Therapeutic Equivalence Guidance for Industry"(Draft)

美国食品药品管理局(FDA)于2022年7月发布了“治疗等效性评价供企业用指导原则”(草案)。该指导原则阐明了FDA治疗等效性的标准以及治疗等效性编码系统,目的是准确评价仿制药与参比制剂的治疗等效性并通过治疗等效性代码,在“橙皮书”中迅速检索到治疗等效的仿制药。而中国目前尚无类似的指导原则,详细介绍FDA该指导原则主要内容,期望对中国加强仿制药的治疗等效性评价和加速完善和实施符合国情的治疗等效性编码系统有所帮助。

The U.S.Food and Drug Administration(FDA)issued"Evaluation of Therapeutic Equivalence Guidance for Industry"(Draft)in July 2022.This guidance explains the FDA’s criteria for therapeutic equivalence and the therapeutic equivalence coding system.The purpose is to accurately evaluate the therapeutic equivalence of generic drugs and reference listed drugs and quickly find therapeutically equivalent generic drugs in the Orange Book through the therapeutic equivalence code.However,there is no similar guidance in China at present.This article introduces the FDA’s guidance in detail,hoping to help that my countrty strengthens the evaluation of the therapeutic equivalence of generic drugs and accelerates the improvement and implementation of the therapeutic equivalence coding system in line with my country’s national conditions.