通過對(duì)ICH Q系列指導(dǎo)原則與我國(guó)對(duì)應(yīng)技術(shù)指導(dǎo)原則的對(duì)比研究，分析我國(guó)藥品注冊(cè)藥學(xué)技術(shù)要求與ICH藥學(xué)技術(shù)要求的主要差異。通過對(duì)公眾、專家、企業(yè)進(jìn)行問卷調(diào)查，摸清ICH Q系列指導(dǎo)原則在我國(guó)的認(rèn)知和實(shí)施基礎(chǔ)。在對(duì)比研究和問卷調(diào)查的基礎(chǔ)上，結(jié)合ICH的要求，提出了ICH Q系列指導(dǎo)原則在我國(guó)實(shí)施的建議。

Through the comparative study of ICH Quality Guidelines and corresponding Chinese technical guidelines, the main differences between Chinese pharmaceutical technical requirements for drug registration and ICH technical requirements for pharmaceutical are analyzed. Through questionnaire survey to the public, experts and enterprises, the cognition and implementation basis of ICH Quality Guidelines in China are found out. On the basis of comparative study and questionnaire survey, combined with the requirements of ICH, the implementation proposals of ICH Quality Guidelines in China are put forward in this paper.

國(guó)家食品藥品監(jiān)督管理總局藥化注冊(cè)司資助項(xiàng)目