文章摘要
关皓月,马玲云,许鸣镝.国外仿制药参比制剂选择简介及对我国的启示[J].中国药事,2018,32(4):445-450
国外仿制药参比制剂选择简介及对我国的启示
Introduction of Selection of Reference Medicinal Product for Foreign Generic Drugs and its Enlightenment to China
投稿时间:2017-07-06  
DOI:10.16153/j.1002-7777.2018.04.004
中文关键词: 参比制剂  仿制药  一致性评价  美国药监局  欧盟
英文关键词: reference medicinal product  generic drug  consistency evaluation  FDA  EU
基金项目:
作者单位
关皓月 中国食品药品检定研究院, 北京 100050 
马玲云 中国食品药品检定研究院, 北京 100050 
许鸣镝 中国食品药品检定研究院, 北京 100050 
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中文摘要:
      目的:为完善我国仿制药一致性评价中参比制剂选择机制和程序提供参考,为仿制药企业在应用选择参比制剂时提供思路。方法:详细介绍了美国FDA有关参比制剂选择指南草案的最新描述,以及欧盟、日本和WHO对于参比制剂的相关要求。结合我国现阶段仿制药一致性评价工作实际,为完善参比制剂选择程序提出建议。结果与结论:美国详细规定了仿制药参比制剂的选择思路和实际操作程序,为我国仿制药参比制剂的选择提供了新的思路。我国正处于仿制药一致性评价参比制剂遴选的关键时期,制定全面、完善的参比制剂遴选体系和机制,有助于规范参比制剂的选择程序,加快一致性评价工作进程,提升我国仿制药一致性评价参比制剂选择的科学性和完整性。
英文摘要:
      Objective: To provide references for the selection mechanism and procedure of reference medicinal product for consistency evaluation in China and to provide ideas for generic enterprises to select the reference medicinal product. Methods: The current reference medicinal product in ANDA draft guidance by US food and drug administration (FDA), as well as the relevant requirements of reference medical product in European Union (EU), Japan and WHO were introduced in details. Some suggestions to improve the selection procedure of reference medicinal product were put forward according to the present situation of consistency evaluation of generic drugs in China. Results and Conclusion: US specifed the ideas and practical operation procedures for the selection of reference medicinal product for generic drugs, which provided new ideas to select the reference medicinal product in China. China is in the critical period of the selection reference medicinal product for generic drugs consistency evaluation. It is necessary to formulate a comprehensive and perfect selection system and mechanism of reference medicinal product, which can help to standardize the selection procedure of reference medicinal product, to speed up the process of consistency evaluation, and to enhance the scientificity and completeness of the selection of reference medicinal product for generic drugs consistency evaluation in China.
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