摘要
目的 为设计上市许可制度中的许可转让程序提供建议。方法 通过查阅文献及国内外法规,分析美欧日药品上市许可转让要素及程序。结果 欧盟对药品上市许可转让实行审批制,美国和日本不对其进行审批,而是分别要求转让双方提交信息或受让方提交转让通知,三种管理方式均关注受让方与转让方责任交接的时间点、受让方承担上市许可持有人责任的承诺及药品相关资料的转移。 结论 我国在设计药品上市许可转让程序时应注意把握转让实质,实行简单的审批制,且监管部门在转让申请前及转让过程中与转让双方及时沟通。
Abstract
OBJECTIVE To put forward several suggestions on designing procedure of authorization transfer in marketing authorization system. METHODS Domestic and foreign regulations and articles were searched.The elements and procedures of marketing authorization transfer in America, Europe and Japan were analyzed.RESULTS Marketing authorization transfer should be reviewed in Europe. In America and Japan, the transfer will not be reviewed, America requires the two sides of transfer to submit some information while Japan requires the transferee submit transfer notifications. These three managements all focus the transfer time of marketing authorization holder′ responsibility, transferee′s commitment of undertaking responsibility and the transfer of related documents. CONCLUSION When design the procedure of marketing authorization transfer, the transfer essence should be catched, and a brief review should be conducted. Moreover, before and during the procedure, there should be some in-time communications between CFDA and two sides of transfer.
关键词
药品 /
上市许可 /
转让 /
审批 /
程序
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Key words
drug /
marketing authorization /
transfer /
review /
procedure
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尤晓敏, 宋洋, 杨悦.
基于药品审评审批改革的药品上市许可转让程序构建研究[J]. 中国药学杂志, 2016, 51(3): 248-252 https://doi.org/10.11669/cpj.2016.03.022
YOU Xiao-min, SONG Yang, YANG Yue.
Research on Establishing the Procedure of Drug Marketing Authorization Transfer Based on Reform of the Drug Review[J]. Chinese Pharmaceutical Journal, 2016, 51(3): 248-252 https://doi.org/10.11669/cpj.2016.03.022
中图分类号：
R951
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参考文献
[1] SHAO R, ZHENG L, HU C X, et al. Constructing a responsibility allocation system for drug safety under institutional arrangement of marketing authorization holder [J]. Chin J Pharm(中国医药工业杂志),2013,44(6):634-638.
[2] European Medicines Agency. Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93 [EB/OL]. [2015-8-15]. Regulation (EC) No 2141/96, 1996-11. http://ec. europa. eu/health/files/eudralex/vol-1/reg_1996_2141/reg_1996_2141_en. pdf
[3] European Medicines Agency. Transfer of marketing authorization: questions and answers[EB/OL]. [2015-8-10]. http://www. ema. europa. eu/ema/index. jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000045. jsp&mid=WC0b01ac0580023e80
[4] CHEN G J, GAO J, HOU Y L, et al. Traditional drug regulatory model will face the challenges of the new system: Authorities in the pharmaceutical industry talk about drug marketing authorization holder(MAH) system [J]. Cap Med(首都医药), 2013,20(13):17-18.
[5] European Medicines Agency. Directive 2001/83/EC of the European parliament and of the council [EB/OL]. (2001-11-6)[2015-8-8]. http://ec. europa. eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en. pdf.
[6] European Directorate for the Quality of Medicines. Guideline on requirements for revision / renewal of certificates of suitability to the European pharmacopoeia monographs [EB/OL]. (2009-12)[2015-8-11]. http://www. edqm. eu/medias/fichiers/guideline_on_requirements_for_revisionrenewal_of_certificates_of_suitability_to_the_european_pharmac1. pdf 2009-12.
[7] CAO X R, BI J, HUANG M. Comparative analysis of domestic and abroad pharmaceutical technology transfer system[J]. Chin J Pharm(中国医药工业杂志), 2014,45(5):498-501.
[8] QIAO Y, CHU S Z. Problem and countermeasure in technology transfer of medicine in China[J]. Shanghai Med Pharm J(上海医药), 2014,35(13):65-66,80.
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脚注
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基金
国家食品药品监督管理局法制司委托课题“药品进出口管理制度研究”资助项目(20150002)
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