美国药品橙皮书框架下治疗等效性评价代码的介绍及启示

Therapeutic Equivalence Evaluation Code under the Framework of American Orange Book

目的介绍美国《经过治疗等效性评价批准的药品目录》(简称“美国药品橙皮书”)下治疗等效性评价代码的基本情况,为我国仿制药一致性评价工作提供借鉴。方法通过研究美国药品橙皮书治疗等效性评价背景、编码规则和意义,结合我国药品监管实际情况,提出完善我国《中国上市药品目录集》(后更名为《新批准上市以及通过仿制药质量和疗效一致性评价的化学药品目录集》,简称“中国药品橙皮书”)治疗等效性评价代码建设的意见。结果和结论治疗等效性评价代码的设置将为药品监管机构、医疗机构、公众带来极大便利,在中国药品橙皮书中标记药品的治疗等效性评价代码既有必要性,也有可能性。我国药品监管机构应从药品治疗等效性评价工作实际出发,借鉴国外经验,建立符合我国国情的治疗等效性评价代码编写规则和程序。

Objective To outline the therapeutic equivalence evaluation code(TE)under the framework of American Orange Book in order to offer some tips on quality and efficacy consistency evaluations of generic drugs in China.Methods The composition,coding rules and significance of the code were studied based on the background of the Orange Book and therapeutic equivalence evaluations in the United States.Ways to improve therapeutic equivalence evaluations in China were proposed.Results and Conclusion The implementation of TE will be of great help to medical institutions,the public,and drug regulatory agencies.In China,it is both necessary and possible to mark TE in the Catalogue of China Approved Drug Products.China's drug regulatory agencies should base their decisions on the current therapeutic equivalence evaluations of drugs in China,learn from other countries,and formulate rules and procedures for TE in line with the realities in China.