我国仿制药发展现状及对策研究

Research on the development status and countermeasures of generic drugs in China

我国的仿制药市场经济规模不断增大,仿制药技术企业得以迅速发展,本文采用文献研究方法,对我国仿制药发展现状及国外代表性国家的仿制药政策进行讨论。通过总结我国仿制药的发展现状,分析我国仿制药发展的困境,对我国仿制药的发展提出可行性建议。但当前还存在仿制药药品质量得不到保证、自主研发能力不足、制剂工艺尚未成熟、质量一致性评价工作进展缓慢等发展困境。通过微观、中观、宏观层面的改善,提高我国仿制药的可及性、满足更多人群的需求,促进其进一步发展。

The growing economic size of the generic drug market in China has led to the rapid development of generic technology companies.In this paper,the current situation of generic drugs development in China and the generic drug policies of representative foreign countries were discussed by means of literature research.By summarizing the development status of generic drugs in china,the difficulties in the development of generic drugs in China were analyzed and feasible suggestions for the development of generic drugs in China were put forward.However,there are still difficulties in current development,such as the lack of quality assurance for generic drugs,insufficient independent R&D capability,immature formulation process and slow progress in quality consistency evaluation.Through improvements at the micro,meso and macro levels,we can improve the accessibility of generic drugs in China to meet the needs of a wider range of people and promote their further development.