仿制药一致性评价工作是当前及今后一段时期医药行业和各级药品监管部门的重点，而参比制剂的遴选是仿制药一致性评价工作的起点、关键和限速步骤，严重影响着一致性评价的方向和进展。作者参与国家食品药品监督管理总局仿制药一致性评价办公室“参比制剂遴选项目组”的工作，现以原料药“苯海拉明”为例，采用各种网络信息手段，检索本品原研信息、美日参比制剂信息及欧洲上市情况，根据我国参比制剂遴选原则，推荐盐酸苯海拉明片25 mg规格参比制剂为持证商Johnson&Johnson Consumer Inc.，McNeil Consumer Healthcare Division，美国上市的同剂型规格制剂。在此基础上，总结原研及参比制剂等相关信息的具体检索途径，为仿制药一致性评价中参比制剂的遴选提供借鉴和参考。

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.