关键词: font-size:medium, ">仿制药；一致性评价；国外经验；比较研究

Abstract: Objective： To conduct a systematic comparative analysis of the consistency evaluation system of generic drugs in the United States， Japan and the EU， and to provide experience reference for the consistency evaluation of generic drugs in China. Methods： Using literature data method， policy analysis method and summary induction method， comparative analyse the relevant practices in the United States， Japan and the European Union， and summarizing experience. Results： The United States， Japan and the European Union have all formulated relevant reference preparation lists and bioequivalence exemption policies， but the re-evaluation methods are different. The United States and the European Union have passed the bioequivalence (BE) test， and the Japanese quality re-evaluation is the use of in vitro dissolution test. Conclusion： China should speed up the formulation of reference preparation catalogues， release bioequivalence exempt varieties， improve the establishment of review institutions， strengthen the management of clinical trial institutions and improve the method of consistency evaluation， so as to promote the construction of consistency evaluation system of generic drugs .
  

Key words: font-size:medium, ">Generic drug； Consistency evaluation； Foreign experience； Comparative research