一致性评价产品目录在美国、日本和WHO的参比制剂概况  

The information of reference drug on the listed varieties in the consistency evaluation of generic drugs in America, Japan and WHO

作　　者：陈泊颖 韩颜[1,2] 徐为人[2] 任晓文[2] CHEN Bo-ying HAN Yan XU Wei-ren REN Xiao-wen(Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China State Key Laboratory of Drug Delivery Technologies and Drug Metabolism, Tianjin Institut of Pharmaceutical Research, Tianjin 300193, China)

机构地区：[1]天津中医药大学研究生院,天津300193 [2]天津药物研究院有限公司天津释药技术与药代动力学国家重点实验室,天津300193

出　　处：《药物评价研究》2016年第5期693-710,共18页Drug Evaluation Research

摘　　要：目的为我国仿制药参比制剂目录的建立提供借鉴和参考。方法简要介绍国内外参比制剂的选择要求,以《2018年底前须完成仿制药一致性评价品种目录》为基础,汇总了世界卫生组织(WHO)、美国橙皮书、日本橙皮书、国家食品药品监督管理总局(CFDA)等数据库的参比制剂信息,并对289个待评价品种的参比制剂概况进行总结。结果 289个参与一致性评价的品种中与国外参比制剂剂型规格均匹配的有126个,与国外的参比制剂的剂型或规格存在差异的有49个,国外没有明确参比制剂的有89个。结论由于匹配的参比制剂数目较少,参比制剂的选择难度较大,因此政府要建立科学有效的评价指标,相关企业也要主动选择参比制剂,主动进行对比研究,尽快推动参比制剂目录的确定。Objective To provide references for the reference drug directory construction of generic drugs in China. Methods The selection of domestic and foreign reference preparation was introduced and information on reference preparation in WHO Orange Book, the US Orange Book, Japan Orange Book and CFDA databases was summaried, which based on the catalog past the consistency of the evaluation by the end of 2018. Results In the 289 varieties whitch involved in of consistency evaluation, there are 126 varieties found that match dosage form and strength in the foreigh reference drug. There are 49 varieties found that different with foreigh reference drug at dosage form or strength. And without a clear reference drug have 87 varieties. Conclusion It is more difficult to make a decision due to the less number of the reference drug. Therefore, the government should establish a scientific and effective evaluation index. The relevant enterprises should actively select and comparative study in the choice of reference drug and to promote the decision of reference drug directory as soon as possible.

关 键 词：仿制药一致性评价 仿制药 参比制剂 橙皮书 

分 类 号：R954[医药卫生—药学]