摘要
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 ge-neric 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 influ-ences 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,Ameri-ca and Japan. The evaluation for generic drugs in USA was reevaluation of the drugs effectiveness under the history of drug registra-tion 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 prepara-tions 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 techni-cal supervision and system supervision.关键词
仿制药/中国/美国/日本/一致性评价/比较研究/生物等效性Key words
Generic drugs/China/America/Japan/Consistency evaluation/Comparative study/Bioequivalence分类
医药卫生
