為及時滿足國內(nèi)臨床用藥需求，國家衛(wèi)生健康委員會分別于2019年10月、2021年2月發(fā)布2批《鼓勵仿制藥品目錄清單》。檢索并整理了《鼓勵仿制藥品目錄（第二批）》納入品種的適應(yīng)證、批準文號數(shù)量、臨床試驗登記等信息，結(jié)合美國食品藥品監(jiān)督管理局（FDA）發(fā)布的生物等效性研究個藥指南，對目錄中涉及的相關(guān)品種生物等效性研究要求進行梳理，結(jié)合品種特征與生物等效性研究要求進行了初步分析，以期為國內(nèi)研究機構(gòu)及企業(yè)開展相關(guān)研究提供科學依據(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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