美國食品藥品管理局（FDA）于2022年7月發(fā)布了"治療等效性評價供企業(yè)用指導原則"（草案）。該指導原則闡明了FDA治療等效性的標準以及治療等效性編碼系統(tǒng)，目的是準確評價仿制藥與參比制劑的治療等效性并通過治療等效性代碼，在"橙皮書"中迅速檢索到治療等效的仿制藥。而中國目前尚無類似的指導原則，詳細介紹FDA該指導原則主要內(nèi)容，期望對中國加強仿制藥的治療等效性評價和加速完善和實施符合國情的治療等效性編碼系統(tǒng)有所幫助。

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.

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