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

doi:10.19803/j.1672-8629.2021.09.04

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (9): 813-816.
DOI: 10.19803/j.1672-8629.2021.09.04

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

李逸云¹, 廖彩云^1,2Δ, 温宝书^1,*

¹国家药品监督管理局药品审评中心,北京 100020;
²中国药科大学,江苏南京 210000

收稿日期:2021-02-15 出版日期:2021-09-15 发布日期:2021-09-18
通讯作者: ^*温宝书,男,硕士,高级工程师,药品审评管理。E-mail：wenbsh@cde.org.cn
作者简介:李逸云,女,硕士,主管药师,药事管理。^Δ为并列第一作者。
基金资助:
重大新药创制国家科技重大专项2017年度 (2017ZX09101001-001-002）

Therapeutic Equivalence Evaluation Code under the Framework of American Orange Book

LI Yiyun¹, LIAO Caiyun^1,2Δ, WEN Baoshu^1,*

¹Center for Drug Evaluation, NMPA, Beijing 100020, China;
²China Pharmaceutical University, Nanjing Jiangsu 210000, China

Received:2021-02-15 Online:2021-09-15 Published:2021-09-18

摘要/Abstract

摘要： 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。

关键词: 药品橙皮书, 治疗等效性评价代码, 治疗等效性评价, 治疗等同药物, 中国上市药品目录集

Abstract: 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.

Key words: Orange Book, therapeutic equivalence evaluations code, therapeutic equivalence evaluation, therapeutically equivalent products, Catalogue of China Approved Drug Products

中图分类号:

R954

李逸云, 廖彩云, 温宝书. 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[J]. 中国药物警戒, 2021, 18(9): 813-816.

LI Yiyun, LIAO Caiyun, WEN Baoshu. Therapeutic Equivalence Evaluation Code under the Framework of American Orange Book[J]. Chinese Journal of Pharmacovigilance, 2021, 18(9): 813-816.

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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

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