生物等效性試驗是評價仿制藥與原研藥質(zhì)量和療效一致性的重要方法，試驗方法的科學(xué)性、評價標準的適用性、數(shù)據(jù)資料的規(guī)范性直接影響對仿制藥質(zhì)量和療效評價的準確性。對中國2020年8月以來累計發(fā)布的48個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）進行逐個匯總、梳理，從多個維度對已發(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)布情況進行概括，結(jié)合美國、歐盟及日本等國際先進監(jiān)管機構(gòu)相關(guān)工作經(jīng)驗，對中國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，進一步滿足臨床需求的同時減輕患者用藥負擔。

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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