為及時(shí)滿足國(guó)內(nèi)臨床用藥需求，國(guó)家衛(wèi)生健康委員會(huì)分別于2019年10月、2021年2月發(fā)布2批《鼓勵(lì)仿制藥品目錄清單》。檢索并整理了《鼓勵(lì)仿制藥品目錄（第二批）》納入品種的適應(yīng)證、批準(zhǔn)文號(hào)數(shù)量、臨床試驗(yàn)登記等信息，結(jié)合美國(guó)食品藥品監(jiān)督管理局（FDA）發(fā)布的生物等效性研究個(gè)藥指南，對(duì)目錄中涉及的相關(guān)品種生物等效性研究要求進(jìn)行梳理，結(jié)合品種特征與生物等效性研究要求進(jìn)行了初步分析，以期為國(guó)內(nèi)研究機(jī)構(gòu)及企業(yè)開(kāi)展相關(guān)研究提供科學(xué)依據(jù)與參考。

To meet the domestic demand for clinical timely, in October 2019 and February 2021, National Health Commission released two batches "Encourage generic drug catalogue". It was sorted out the indications, the number of approval and the registration of clinical trials in "Encourage generic drug catalogue (the second batch)" in this paper. The bioequivalence requirements of preparations in this catalogue by US Food and Drug Administration (FDA) were summarized and several analyses were put forward based on this characteristics, aimed to provide scientific reference for research and development on this kind of drugs.

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