欧盟仿制药参比制剂检索与确认简介

doi:10.5246/jcps.2018.11.081

中国药学(英文版) ›› 2018, Vol. 27 ›› Issue (11): 805-812.DOI: 10.5246/jcps.2018.11.081

• 【药事管理与临床药学专栏】 • 上一篇下一篇

欧盟仿制药参比制剂检索与确认简介

牛剑钊, 杨东升, 许鸣镝^*

中国食品药品检定研究院, 北京 100050

收稿日期:2018-08-30 修回日期:2018-10-16 出版日期:2018-11-28 发布日期:2018-10-23
通讯作者: Tel.: +86-010-67095371, E-mail: xumingdi@nifdc.org.cn
基金资助:
National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’ (Grant No. 2017ZX09101001, Beijing, China).

Brief introduction for search and determination of the comparator product for generic medicinal product application in the EU

Jianzhao Niu, Dongsheng Yang, Mingdi Xu^*

National Institutes for Food and Drug Control, Beijing 100050, China

Received:2018-08-30 Revised:2018-10-16 Online:2018-11-28 Published:2018-10-23
Contact: Tel.: +86-010-67095371, E-mail: xumingdi@nifdc.org.cn
Supported by:
National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’ (Grant No. 2017ZX09101001, Beijing, China).

摘要/Abstract

摘要：

参比制剂的选择是仿制药开发和研究的一个重要环节。国家食品药品监督管理总局相关公告明确了用于仿制药质量与疗效一致性评价或仿制药申请时的参比制剂应为原研药品或国际公认的同种药物。为了帮助国内外仿制药企业正确检索和确定欧盟的参比制剂, 本文详细介绍了欧盟药品的四种审评方式及相应的上市产品目录。同时以检索仿制药米非司酮片(200 mg)在欧盟上市申请时须选用的参比制剂为例, 结合不同的上市产品目录详细介绍了检索和确定欧盟仿制药的参比制剂过程。

关键词: 参比制剂, 仿制药质量与疗效一致性评价, 上市许可申请, 米非司酮片

Abstract:

It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China Food and Drug Administration (CFDA) that the comparator product should be innovator product or internationally recognized same medicinal product, which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal product. To facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product, four medicinal product evaluation procedures, as well as the corresponding marketed medicinal product list, are detailed elaborated in this paper. At the same time, by taking the Mifepristone Tablet (200 mg) as example, the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.

Key words: Comparator product, Re-evaluation of generic medicinal product, Marketing authorization application, Mifepristone tablet

中图分类号:

R951

Supporting:

牛剑钊, 杨东升, 许鸣镝. 欧盟仿制药参比制剂检索与确认简介[J]. 中国药学(英文版), 2018, 27(11): 805-812.

Jianzhao Niu, Dongsheng Yang, Mingdi Xu. Brief introduction for search and determination of the comparator product for generic medicinal product application in the EU[J]. Journal of Chinese Pharmaceutical Sciences, 2018, 27(11): 805-812.

参考文献

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[2] China Food and Drug Administration. Announcement on the issuance on filing and recommendation procedures for the Comparator Product used in the Re-evaluation of Generic Medicinal Product (No. 99 in 2016) [EB/OL]. [2016-05-19]. http://www.sda.gov.cn/WS01/CL1757/153485.html

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[7] Coordination Group for Mutual Recognition and Decentralised Procedure (human). CMDh WORKING DOCUMENT - INFORMATION TO BE SUBMITTED BY THE MEMBER STATE OF THE EUROPEAN REFERENCE MEDICINAL PRODUCT [EB/OL]. [2016-10]. http://www.hma.eu/fileadmin/dateien/Human_ Medicines/CMD_h_/procedural_guidance/Generics/CMDh_088_2006_Rev03_2016_10_clean.pdf

[8] HMA. Public Assessment Report: Lacidipine Double-e Pharma 2 mg,4 mg and 6 mg film-coated tablets. [EB/OL]. [2016-07-28]. http://mri.cts-mrp.eu/download/NL_H_2992_001_PAR.pdf

[9] European Commission. NOTICE TO APPLICANTS, VOLUME 2A Procedures for marketing authorisation CHAPTER 1 MARKETING AUTHORISATION [EB/OL]. [2016-12]. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/vol2a_chap1_rev6_201612.pdf

[10] European Commission. Community Register of medicinal products [EB/OL]. [2017-02-23]. http://ec.europa.eu/health/documents/community-register/html/index_en.htm

[11] Coordination Group for Mutual Recognition and Decentralised Procedure (human). MRI Product Index [EB/OL]. [2018-08-29]. https://mri.cts-mrp.eu/Human/

[12] United Kingdom. Marketing authorisations: lists of granted licences [EB/OL]. [2014-12-18]. https://www.gov.uk/ government/collections/marketing-authorisations-lists-of-granted-licences

欧盟仿制药参比制剂检索与确认简介

Brief introduction for search and determination of the comparator product for generic medicinal product application in the EU

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