在仿制藥研究過程中通過體外評價方法替代體內(nèi)生物等效性研究可以減少臨床資源消耗，加快藥品上市進度，這是基于生物藥劑學(xué)分類系統(tǒng)（BCS）的生物等效性豁免的主要原因。隨著我國仿制藥的快速發(fā)展，企業(yè)基于BCS的生物豁免申請需求越來越迫切，當(dāng)藥物制劑為具有全身作用的普通口服制劑，且藥物活性成分符合溶解性和滲透性（BCS I和III類）標(biāo)準(zhǔn)，受試制劑劑型和規(guī)格與參比制劑相同，可適用基于BCS的生物等效性豁免。對國內(nèi)外的基于BCS分類的生物豁免研究進展和法規(guī)進行綜述，并對具體操作及申報要求提出一些思考。

The purpose of biowaiver based on biopharmaceutical classification system (BCS) is to replace in vivo bioequivalence study by in vitro evaluation method, which can reduce the consumption of clinical resources and accelerate the progress of drug marketing. With the rapid development of generic drugs in China, there is an increasingly demand for sponsors to apply for biowaiver based on BCS classification. The biowaiver based on BCS is applicable if the active ingredients of the drug meet the solubility and permeability (BCSI and III) standards, and the drug preparation is a general oral preparation with systemic effect, and the dosage form and specification of the test preparation are the same as the reference preparation. This paper summarizes the research progress and regulations of biowaiver based on BCS classification at home and abroad, and puts forward some thoughts on the specific operation and application requirements.

R945

“重大新藥創(chuàng)制”國家科技重大專項（2017ZX09101001）；基于BCS分類及體內(nèi)外相關(guān)性的生物豁免研究（2017ZX0901001-004）