為及時滿足國內(nèi)臨床用藥需求，2019年10月，國家衛(wèi)生健康委員會正式發(fā)布《關(guān)于印發(fā)第一批鼓勵仿制藥品目錄的通知》。檢索并整理了全部納入品種的適應(yīng)癥、批準(zhǔn)文號數(shù)量、臨床試驗登記等信息，結(jié)合美國食品藥品管理局（FDA）發(fā)布的生物等效性研究個藥指南，對目錄中涉及的固體口服制劑生物等效性研究要求進(jìn)行梳理，并結(jié)合涉及品種的相關(guān)特征與生物等效性研究要求進(jìn)行分析，以期為國內(nèi)研究機(jī)構(gòu)及原研企業(yè)開展相關(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, National health commission released "Encourage generic drug catalogue(the first batch)". In this paper, we sorted out the indications, the number of approval and the registration of clinical trials in this catalogue. The bioequivalence requirements of the solid oral preparations in this catalogue by FDA were summarized and several analysis were put forward based on this characteristics. aimed to provide scientific reference for research and development on this kind of drugs.

R915;R951