化学药品仿制药眼用制剂质量研究总体要求和关注点探讨

Discussion on the overall requirements and focus points for quality research of chemical generic ophthalmic preparations

由于眼部的敏感性及独特的解剖学和生理学特点,相比其他外用制剂,眼用制剂在质量控制方面要求更为严格。在文献调研和日常审评工作基础上,主要参考国内外相关技术指南及法规要求,对化学药品仿制药眼用制剂的质量研究进行探讨,主要包括质量研究的总体要求及主要关注点,如微生物方面的考虑、释放或溶出及稳定性设计等。通过本文的探讨,以期为业界仿制药眼用制剂尤其是复杂制剂的开发或为我国监管机构提供参考。

Due to the sensitivity of the eyes and their unique anatomical and physiological characteristics,ophthalmic preparations require stricter quality control compared to other topical preparations.Through preliminary literature research and daily review,mainly based on the relevant domestic/foreign technical guidelines and regulatory requirements,we discuss the quality research of chemical generic ophthalmic preparations.This mainly included the overall requirements for quality research and other concerns,such as microbiological considerations,drug release/dissolution,and stability design.Through the discussion in this article,we hope to provide some reference for the development of generic ophthalmic preparations,especially complex preparations or for regulatory agencies in China.