創(chuàng)新藥研發(fā)是一個探索性的研究過程，具有不同于仿制藥的研發(fā)規(guī)律和研究特點，研究和審評應遵循其規(guī)律有序開展。參考FDA、歐盟發(fā)布的IND申請藥學相關(guān)技術(shù)指南，結(jié)合筆者近年來的審評實踐，對創(chuàng)新藥藥學研發(fā)的特點、階段性的技術(shù)要求進行討論，并介紹近期國內(nèi)創(chuàng)新藥審評的相關(guān)政策。

As R&D of innovative drugs is an exploratory process, the research and evaluation of innovative drugs should follow its own rules. Based on INDs review experience, referring to FDA and EMA's guidelines on CMC information of INDs, this article is intended to introduce CMC R&D characteristics of innovative drugs, and discuss the phase-dependent CMC requirements for INDs.