目的 為我國仿制藥質(zhì)量與療效一致性評價的生物等效性試驗，提供可豁免藥物品種的參考。方法 以《人體生物等效性試驗豁免指導(dǎo)原則（征求意見稿）》為基礎(chǔ)，以我國一致性評價的首批藥物為前提，簡要介紹和歸納美國食品藥品管理局（FDA）、世界衛(wèi)生組織（WHO）、歐洲藥品局（EMA）的生物等效性試驗豁免的標(biāo)準(zhǔn)和可申請豁免的藥物品種。結(jié)果 對比FDA，289個一致性評價藥物品種中可申請豁免的有59個，不可申請豁免的有19個；對比WHO，可豁免的藥物有10個，EMA中有1個。結(jié)論 目前，我國生物等效性試驗豁免的具體藥物名單尚未公布，企業(yè)應(yīng)該對比參考國內(nèi)外的相關(guān)標(biāo)準(zhǔn)和具體藥物，以加快一致性評價工作的進(jìn)展。

Objective For bioequivalence test of the consistency evaluation of generic drug products, providing a reference of varieties of biowaiver.Methods Based on Human bioequivalence test waiver guidelines (draft), on condition that first drug of the consistency evaluation, to introduce and conclude briefly the standards of biowaiver and varieties of biowaiver in FDA, WHO and EMA.Results Contrast to FDA, there are 59 varieties applied for the waiver and 19 varieties not applied for the waiver in the 289 varietie; compared to WHO, 10 drugs are exempted and 1 grug is exempted in EMA.Conclusion At present, the specific list of drugs are not published of biowaiver in our country, the pharmaceutical companies should compare and consult revelant standards and specific drugs in China and abroad, to speed up the progress of the consistency evaluation.