仿制药注射剂处方工艺研究中的相关技术要求

Technical requirements of the research on formula and preparation process of the generic drug product

仿制药目前在我国研发药品总量中占主导地位,与新药一起为公众健康用药提供了有力的保障。仿制注射剂作为很重要的一类仿制药,基于给药途径而对其质量提出更高要求。文中结合"质量一致性"原则,对现阶段仿制注射剂在处方工艺研究中需要关注的几个技术要求进行了归纳与分析,以期促进仿制药评价体系的不断完善,提高评价水平;也引导药品研发者有的放矢,提高研发效率。

Generic drug is a main component of all drug products in China,and ensures the safe use by the public together with innovative drug.The generic injection is the most important type in all generic drugs because its route of administration needs the highest requirement of quality control than any others.In order to further improve our generic drug evaluation system and the quality of our evaluation and to enhance the efficiency of drug research and development,this article points out some requirements on preparation research of generic injection based on the principle of ＂The quality coherence between the innovative and the generic drug＂.