參比制劑是指用于仿制藥開發(fā)的對照藥品，是仿制藥研發(fā)過程中的關鍵因素之一，也是有效進行仿制藥開發(fā)以及開展一致性評價工作的重要條件。化學仿制藥參比制劑遴選相關政策及其目錄的發(fā)布與執(zhí)行，有效推動了我國化學仿制藥一致性評價工作的進程，也為藥品安全性、有效性的科學監(jiān)管奠定了堅實基礎。通過對2020年1月-2021年10月中國化學仿制藥參比制劑目錄（公示稿）中遴選未通過品種進行梳理，初步分析落選品種的主要特征，結合落選原因提出一般建議，為有序推進化學仿制藥參比制劑遴選以及化學仿制藥品的立項與研發(fā)提供依據(jù)與參考。

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.

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