通過對ICH S系列指導原則與我國相應技術指導原則的對比研究，分析我國與ICH在藥品注冊非臨床技術要求方面的主要差異。通過對公眾、專家、企業(yè)進行問卷調(diào)查，摸清ICH S系列指導原則在我國的認知和實施基礎。在對比研究和問卷調(diào)查的基礎上，結合ICH的要求，提出了ICH S系列指導原則在我國實施的建議。

Through the comparative study of ICH Safety Guidelines and corresponding Chinese technical guidelines, the main differences in non-clinical technical requirements for drug registration between China and ICH are analyzed. Through questionnaire survey to the public, experts and enterprises, the cognition and implementation basis of ICH Safety 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 Safety Guidelines in China are put forward in this paper.

國家食品藥品監(jiān)督管理總局藥化注冊司資助項目