我国实施ICHS系列技术指导原则的策略研究

Strategic research on implementation of ICH Safety Guidelines in China

通过对ICH S系列指导原则与我国相应技术指导原则的对比研究,分析我国与ICH在药品注册非临床技术要求方面的主要差异。通过对公众、专家、企业进行问卷调查,摸清ICH S系列指导原则在我国的认知和实施基础。在对比研究和问卷调查的基础上,结合ICH的要求,提出了ICH S系列指导原则在我国实施的建议。

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.