參比制劑是指用于仿制藥開(kāi)發(fā)的對(duì)照藥品，是仿制藥研發(fā)過(guò)程中的關(guān)鍵因素之一，也是有效進(jìn)行仿制藥開(kāi)發(fā)以及開(kāi)展一致性評(píng)價(jià)工作的重要條件?；瘜W(xué)仿制藥參比制劑遴選相關(guān)政策及其目錄的發(fā)布與執(zhí)行，有效推動(dòng)了我國(guó)化學(xué)仿制藥一致性評(píng)價(jià)工作的進(jìn)程，也為藥品安全性、有效性的科學(xué)監(jiān)管奠定了堅(jiān)實(shí)基礎(chǔ)。通過(guò)對(duì)2020年1月-2021年10月中國(guó)化學(xué)仿制藥參比制劑目錄（公示稿）中遴選未通過(guò)品種進(jìn)行梳理，初步分析落選品種的主要特征，結(jié)合落選原因提出一般建議，為有序推進(jìn)化學(xué)仿制藥參比制劑遴選以及化學(xué)仿制藥品的立項(xiàng)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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