生物等效性試驗(yàn)是評(píng)價(jià)仿制藥與原研藥質(zhì)量和療效一致性的重要方法，試驗(yàn)方法的科學(xué)性、評(píng)價(jià)標(biāo)準(zhǔn)的適用性、數(shù)據(jù)資料的規(guī)范性直接影響對(duì)仿制藥質(zhì)量和療效評(píng)價(jià)的準(zhǔn)確性。對(duì)中國(guó)2020年8月以來(lái)累計(jì)發(fā)布的48個(gè)特定藥物生物等效性研究技術(shù)指導(dǎo)原則（含征求意見稿16個(gè)）進(jìn)行逐個(gè)匯總、梳理，從多個(gè)維度對(duì)已發(fā)布的特定藥物生物等效性研究技術(shù)指導(dǎo)原則的發(fā)布情況進(jìn)行概括，結(jié)合美國(guó)、歐盟及日本等國(guó)際先進(jìn)監(jiān)管機(jī)構(gòu)相關(guān)工作經(jīng)驗(yàn)，對(duì)中國(guó)特定藥物生物等效性研究技術(shù)指導(dǎo)原則的發(fā)布情況提出一般考慮，以期提高仿制藥質(zhì)量和療效，進(jìn)一步滿足臨床需求的同時(shí)減輕患者用藥負(fù)擔(dān)。

Bioequivalence is an important method to evaluate the consistency of quality and efficacy between generic drug and original drug. The scientificity of test method, applicability of evaluation criteria and standardization of data directly affect the evaluation accuracy of generic drug. In this paper, 48 technical guidelines for bioequivalence of specific drugs (including 16 draft for comment) released since August 2020 in China were summarized and sorted, and guidelines for bioequivalence research of specific drugs have been summarized from multiple dimensions. Combined with the relevant experience of international advanced regulatory agencies such as United States, European Union and Japan, in order to improve the quality and efficacy of generic drugs in China, further meet the clinical require of patients and reduce the burden of medication, general considerations were put forward for China bioequivalence guidelines of specific drugs.

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