中美日仿制药一致性评价政策比较研究
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篇名: 中美日仿制药一致性评价政策比较研究
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摘要: 目的:对中美日三国仿制药一致性评价政策进行比较研究,为我国仿制药质量和疗效一致性评价政策的完善提供参考。方法:以“仿制药”“一致性评价”“Generic drug”“Quality evaluation”“DESI”等为主题词检索1950年1月1日-2016年6月30日在中国知网、Web of Science、Elsevier、Springer数据库以及美国FDA等网站中发表或报道的相关文献或信息,对中美日三国仿制药一致性评价政策出台的历史背景、评价方法、政策实施效果等进行比较分析。结果:中美日三国仿制药一致性评价政策出台的历史背景、评价方法、参与主体及政策影响力均不同。美国针对历史上药品法规不完善进行的药品有效性再评价,采用专家团队进行审查,依据FDA、企业、科学文献三方证据以及专家所长进行评价;日本仿制药再评价主要采用体外溶出试验的方法;我国仿制药一致性评价的重点在于仿制药市场准入评价,主要采用体内生物等效性评价方法,参比制剂的标准从原基本类似药品逐步上升为原研药。结论:与美日等以创新药为主的国家相比,我国仿制药评价中参比制剂可获得性较低,政策环境更为复杂。我国应进一步完善法律法规,给予仿制药企业合理的缓冲期,并充分考虑评价方法的多样性、特殊情况的豁免情形以及我国医药工业的现状,注重技术监管与制度监管的平衡。
ABSTRACT: OBJECTIVE: To study the consistency policies of generic drugs in China, America and Japan comparatively, and provide reference for perfecting quality and efficacy consistency evaluation of generic drugs in China. METHODS: “Generic drug” “Consistency evaluation” “Quality evaluation” “DESI” were used as keywords to search the related literatures or information of generic drugs published or reported in CNKI, Web of Science, Elsevier, Springer database and USA FDA website during Jan. 1st, 1950-Jun. 30th, 2016. And comparative analysis was conducted for the historical background, evaluation methods and policy influences of consistency policies of generic drugs in China, America and Japan. RESULTS: There were differences in the historical background, evaluation methods, major participants and policy influences of consistency policies of generic drugs in China, America and Japan. The evaluation for generic drugs in USA was reevaluation of the drugs effectiveness under the history of drug registration regulation was imperfect. With experts’ review, it was evaluated based on FDA, enterprises, scientific literature evidence and experts review. Main evaluation method was in vitro dissolution test in Japan. The consistency evaluation of generic drug in China focused on the generic drug marketing authorization, mainly using in vivo bioequivalence. And the standards of reference preparations were from the basically similar drugs to the original drugs. CONCLUSIONS: Compared with innovation-based countries like America and Japan, the availability of reference preparations in China is low, and policy environment is more complex. China should further improve the laws and regulations, giving reasonable buffer period, considering the diversity of evaluation methods, exemptions in special circumstances and current situation of pharmaceutical industry, paying attention to the balance between technical supervision and system supervision.
期刊: 2017年第28卷第25期
作者: 王青宇,杨悦
AUTHORS: WANG Qingyu,YANG Yue
关键字: 仿制药;中国;美国;日本;一致性评价;比较研究;生物等效性
KEYWORDS: Generic drugs; China; America; Japan; Consistency evaluation; Comparative study; Bioequivalence
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