仿制藥一致性評(píng)價(jià)工作是當(dāng)前及今后一段時(shí)期醫(yī)藥行業(yè)和各級(jí)藥品監(jiān)管部門的重點(diǎn)，而參比制劑的遴選是仿制藥一致性評(píng)價(jià)工作的起點(diǎn)、關(guān)鍵和限速步驟，嚴(yán)重影響著一致性評(píng)價(jià)的方向和進(jìn)展。作者參與國家食品藥品監(jiān)督管理總局仿制藥一致性評(píng)價(jià)辦公室“參比制劑遴選項(xiàng)目組”的工作，現(xiàn)以原料藥“苯海拉明”為例，采用各種網(wǎng)絡(luò)信息手段，檢索本品原研信息、美日參比制劑信息及歐洲上市情況，根據(jù)我國參比制劑遴選原則，推薦鹽酸苯海拉明片25 mg規(guī)格參比制劑為持證商Johnson&Johnson Consumer Inc.，McNeil Consumer Healthcare Division，美國上市的同劑型規(guī)格制劑。在此基礎(chǔ)上，總結(jié)原研及參比制劑等相關(guān)信息的具體檢索途徑，為仿制藥一致性評(píng)價(jià)中參比制劑的遴選提供借鑒和參考。

The generic drug consistency evaluation is the focus of pharmaceutical industry and drug regulatory authorities for the current and future period, while reference drug selection is the key starting point and rate-limiting step of consistency evaluation work, which seriously affects the direction and progress of generic drug consistency evaluation. Author participated in the work of the "Reference Drug Selection Project Team" of SFDA Generic Drugs Consistency Evaluation Office, now taking the Active Pharmaceutical Ingredient "Diphenhydramine" as an example, using various network information means to search for the original research information, US and Japan reference drug information and European marketing information of the product, then according to the principle of reference drugs selection in China, it is recommended that diphenhydramine hydrochloride tablets 25 mg is the holder of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division with the same dosage form specification as reference durg. Based on above, this article summary the specific search methods of the original research and reference drugs etc. related information, to provide reference for the selection of reference drug in the generic drug consistency evaluation.