浅析质量管理在仿制药一致性评价中的发展

Analysis on the Development of Quality Management in the Consistency Evaluation of Generic Drugs

仿制药能够在保证药品疗效的基础上节约研发成本,在我国医疗行业当前的发展中,仿制药成为最为重要的药品生产方式.基于对仿制药一致性评价概念和要求的了解与探究,本文指出了质量管理在仿制药一致性评价中的发展模式,并在此基础上提出质量管理理念在仿制药一致性评价中的应用方法,让我国的仿制药工艺获得更好发展.

Generic drugs can save the cost of research and development on the basis of ensuring the efficacy of drugs.In the current development of China's medical industry,generic drugs have become the most important mode of drug production.Based on the understanding and exploration of the concept and requirements of generic drug consistency evaluation,this paper points out the development mode of quality management in generic drug consistency evaluation,and puts forward the application method of quality management concept in generic drug consistency evaluation on this basis,so that China's generic drug technology can achieve better development.