中美日仿制药一致性评价政策比较研究

发布时间：2018-07-05 06:06

本文选题：仿制药 + 中国　；参考：《中国药房》2017年25期

【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 compare and study the consistency evaluation policies of generic drugs in China, America and Japan, so as to provide reference for the improvement of the consistency evaluation policies of quality and efficacy of generic drugs in China. Methods: generic drug, quality evaluation, and Desi were used as the theme words to retrieve the relevant literature or information published or reported in the Web of Science Elsevierspinger database and the Web of FDAs in China from January 1, 1950 to June 30, 2016. This paper makes a comparative analysis of the historical background, evaluation methods and implementation effect of the consistency evaluation policy of generic drugs in China, the United States and Japan. Results: the historical background, evaluation methods, participants and policy influence of the consistency evaluation policy of generic drugs in China, the United States and Japan were different. In view of the reevaluation of drug effectiveness in the history of imperfect drug laws and regulations, the United States adopts a team of experts to conduct a review, which is based on the tripartite evidence of FDAs, enterprises, scientific literature and expert director. In Japan, the reevaluation of generic drugs mainly adopts the method of dissolution test in vitro. The emphasis of the consistency evaluation of generic drugs in China lies in the market access evaluation of generic drugs, and the in vivo bioequivalence evaluation method is mainly used. The standard of reference preparation was gradually raised from the original basic similar drug to the original research drug. Conclusion: compared with other countries, such as America and Japan, the reference preparation in the evaluation of generic drugs in China is less available and the policy environment is more complex. China should further perfect the laws and regulations, give the generic pharmaceutical enterprises a reasonable buffer period, and give full consideration to the diversity of evaluation methods, the exemption of special circumstances and the current situation of the pharmaceutical industry in our country, and pay attention to the balance between technical supervision and system supervision.
【作者单位】：沈阳药科大学工商管理学院;郑州大学药学院;
【分类号】：R951

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