论文部分内容阅读
目的为提升我国仿制药的研发水平,推动我国仿制药进入国际市场,提出我国仿制药研究和评价亟需建立的新理念。方法调研国际上仿制药研发与评价管理的新趋向以及国内仿制药的发展现状,并总结思考。结果与结论提出质量源于设计理念的应用、仿制药豁免临床试验的科学考虑以及通用技术文件(CTD)申报格式的推行对于促进我国仿制药的发展具有重要意义。
The purpose is to promote the level of research and development of generic drugs in our country and to promote the access of generic drugs to the international market in our country. We put forward the new concept which is urgently needed to be established in the research and evaluation of generic drugs in our country. Methods Investigate the new trends of international generic drug research and development and evaluation management and the status quo of domestic generic drugs and summarize and reflect on them. Results and Conclusions It is of great importance to promote the development of generic drugs in China by proposing that the application of quality from design concept, the scientific consideration of generic exemption from clinical trials and the implementation of the generic technical document (CTD) reporting format.