我国化学仿制药参比制剂落选品种的特征分析

Analysis and consideration of chemical generic drug reference selection by failed application characteristic in China

参比制剂是指用于仿制药开发的对照药品,是仿制药研发过程中的关键因素之一,也是有效进行仿制药开发以及开展一致性评价工作的重要条件。化学仿制药参比制剂遴选相关政策及其目录的发布与执行,有效推动了我国化学仿制药一致性评价工作的进程,也为药品安全性、有效性的科学监管奠定了坚实基础。通过对2020年1月—2021年10月中国化学仿制药参比制剂目录(公示稿)中遴选未通过品种进行梳理,初步分析落选品种的主要特征,结合落选原因提出一般建议,为有序推进化学仿制药参比制剂遴选以及化学仿制药品的立项与研发提供依据与参考。

Reference list drug(RLD)refers to the reference drugs used in the research of generic drugs,which is one of the key factors in the development of generic drugs,and an important prerequisite for effective generic drug development and consistency evaluation.The policies and catalogues on RLD selection release and implementation for chemical generic drugs have effectively promoted the consistency evaluation of chemical generic drugs in China,and laid a solid foundation for the scientific supervision of drug safety and effectiveness.The main characteristics of the varieties that refused RLD applies were analyzed by combing the catalogue of RLD for chemical generics in China(public draft)from January 2020 to October 2021,and considerations were put forward in combination with various reasons for the failed applies.Aim to provides basis and reference for the promotion of reference selection as well as the projects establishment and development of chemical generic drugs.