Objective: To provide suggestions for consistency evaluation in China. Methods: According to the basic principle of "Quality by Design" and its practical experience in the research and development of generic drugs, the diffculties in the consistency evaluation of generic drugs in China were analyzed and some suggestions were put forward. Results and Conclusion: The quality of generic drugs and the standardization of application materials could be significantly improved based on the concept of "Quality by Design", while the efficiency of regulation and evaluation were promoted. Moreover, a stable and effcient process flow was designed in the product development phase based on the application of "Quality by Design", and a solid foundation for clinical bioequivalence validation was laid, which is conducive to realizing the "consistency" and "clinical substitution" between generic drugs and original drugs.
Key words
generic drugs;consistency evaluation;quality by design;application materials;efficiency of evaluation
{{custom_keyword}} /
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
References
[1] 国家食品药品监督管理总局. 数据查询[EB/OL].[2017-06-18]. http://qy1.sfda.gov.cn/datasearch/face3/dir.html.
[2] 国务院. 国办发[2016] 8号关于开展仿制药质量和疗效一致性评价的意见[S]. 2016.
[3] 中华人民共和国药品管理法[J]. 中华人民共和国公安部公报,2015,(4):32-41.
[4] 王大为. 适用性:质量概念之魂[J]. 中国技术监督, 2000,(11):61-62.
[5] 余珊珊,张正付,李正奇. 仿制药一致性评价现状调查及对策[J]. 中国临床药理学与治疗学,2015,20(1):118-120.
[6] 林兰,牛剑钊,许明哲,等. 国外仿制药一致性评价比较分析[J]. 中国新药杂志,2013,(21):2470-2474.
[7] 郑洁,陈玉文. 日本药品品质再评价工程对我国仿制药一致性评价的借鉴[J]. 中国药业,2014,(18):6-7.
[8] 牛剑钊,林兰,马锐,等. 我国仿制药研究及监管现状[J]. 中国新药杂志,2014,(1):6-10.
[9] 国家食品药品监督管理总局. 2016年第106号公告关于落实《国务院办公厅关于开展仿制药质量和疗效一致性评价的意见》有关事项的公告[S]. 2016.
[10] 仲小燕,梁毅. 实施"质量源于设计"的五个关键因素[C]//中国药学会药事管理专业委员会年会暨"十二五药事管理学科发展与药品监管工作建设"学术研讨会,2011:14-17.
[11] Zhang L, Mao S. Application of Quality by Design in the Current Drug Development[J]. Asian Journal of Pharmaceutical Sciences, 2016, 12(1):1-8.
[12] Yu L X, Amidon G, Khan M A, et al. Understanding Pharmaceutical Quality by Design[J]. Aaps Journal, 2014, 16(4):771-783.
[13] 刘理文. QbD在仿制药工程的应用路径设计[D]. 厦门:厦门大学,2014.
[14] 王明娟,胡晓茹,戴忠,等. 新型的药品质量管理理念"质量源于设计"[J]. 中国新药杂志,2014,(8):948-954.
[15] 梁毅. GMP教程[M]. 北京:中国医药科技出版社, 2015:169-179.
{{custom_fnGroup.title_en}}
Footnotes
{{custom_fn.content}}
PDF(1012 KB)
