創(chuàng)新藥研發(fā)是一個(gè)探索性的研究過(guò)程，具有不同于仿制藥的研發(fā)規(guī)律和研究特點(diǎn)，研究和審評(píng)應(yīng)遵循其規(guī)律有序開(kāi)展。參考FDA、歐盟發(fā)布的IND申請(qǐng)藥學(xué)相關(guān)技術(shù)指南，結(jié)合筆者近年來(lái)的審評(píng)實(shí)踐，對(duì)創(chuàng)新藥藥學(xué)研發(fā)的特點(diǎn)、階段性的技術(shù)要求進(jìn)行討論，并介紹近期國(guó)內(nèi)創(chuàng)新藥審評(píng)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.